FORM FDA 3500A SUPPLEMENT

1 GENERAL instructions for form FDA 3500A MedWatch (for Mandatory reporting) All entries should be typed or printed in a font nosmaller than 8 point. Complete all sections that apply. If information isunknown, not available or does not apply, the sectionshould be left blank. Dates should be entered as dd-mmm-yyyy ( ,October 12, 2016 = 12 Oct 2016). If exact dates areunknown, provide the best estimate. For narrative entries, if the fields do not provideadequate space, attach an additional page(s). Thefollowing specific information is to be incorporated: Include the word continued at the end of each fieldof FDA form 3500A that has additional informationcontinued onto another page Identify all attached pages as Page __ of __ Indicate the appropriate section and block numbernext to the narrative continuation Display the User Facility, Importer, or Manufacturer/Compounder report number in the upper rightcorner as applicable Include the firm s or facility s name in the upperright corner as well, if the report is from a userfacility, importer, or manufacturer If the case report involves more than two (2) suspectproducts attach another copy of form FDA 3500A ,with only section C filled in as appropriate.

2 For a user facility, if more than one medical device issuspected to have caused or contributed to a patientdeath or serious injury, the user facility can submitone report for the event. Prepare a complete FormFDA 3500A for the device that is most likely to havecaused or contributed to the event and a separateForm FDA 3500A with only section D (SuspectMedical Device) and Blocks F9, F10, F13, and F14filled in for each additional device. Identify each reportas device 1, device 2, etc. A user facility is required to report a device-relateddeath or a device-related serious injury to themanufacturer and to report a device-related death toFDA. Manufacturers must prepare and submit a completeForm FDA 3500A for each suspect form FDA 3500A will be given a separateManufacturer Report Number. If the suspect medical device is a single use devicethat has been reprocessed for use in humans,then the reprocessor is the manufacturer.

3 Themanufacturer can be either an Original EquipmentManufacturer (OEM), or a Reprocessor of Single-Use Devices, which also can be a User Facility thatreprocesses Single-Use Devices. (See the followingtable.)Subject Device is: Manufacturer is: Single Use Device Original Equipment Manufacturer (OEM) Device designed to be reused Original Equipment Manufacturer (OEM) Single Use Device, reprocessed for reuse Reprocessor Single Use Device, reprocessed by Hospital or Health Care Facility Hospital or Health Care Facility If no suspect medical device is involved in a reportedadverse event ( , when reporting ONLY a suspectdrug or biologic), ONLY sections A, B, C, E, and G areto be filled out: Section G (All manufacturers) may be substitutedfor section D (Suspect medical device) on the frontof the form to enable the submission of a one pageform If section G is reproduced on the front of the formit must be an identical reproduction of the originalsection G All submissions must be made in English, includingforeign literature reports.

4 Vaccines: adverse events involving vaccines shouldbe reported to the Vaccine Adverse Event ReportingSystem (VAERS), Foradditional information or assistance with filing aVAERS report, call: 1-800-822-7967. Devices: Federal law provides that user facility reportsthat are required by law may not be used in privatecivil litigation actions unless the party who madethe report had knowledge the report contained falseinformation. 21 USC 360i(b)(3).FRONT PAGE At the top of the front page Enter the page number and total number of pages submitted (include attachments in the total) where the words Page __ of __ are indicated. On the top-right corner of the front page, enter the Manufacturer report number, User Facility report number, or Importer report number in the correspondingly labeled box. Enter both report numbers, if applicable, to cross-reference this report with a report from another source on the same event.

5 Manufacturer report #: This is the unique identifier used by the manufacturer for this report. For a follow-up report, the manufacturer report number must be identical to the number assigned to the initial report. The manufacturer report number is also entered in block G9 on the back of the form . form FDA 3500A SUPPLEMENT (4/16) form instructions Page 1 of 15 PSC Publishing Services (301) 443-6740 EF GENERAL instructions (Continued) For device manufacturers: The report numberconsists of three components: the manufacturer sFDA registration number for the manufacturing site ofthe reported device, the 4-digit calendar year, and aconsecutive 5-digit number for each report filed duringthe year by the manufacturer ( , 1234567-2016-00001, 1234567-2016-00002). If the manufacturingsite does not have a registration number, then FDAwill assign a temporary one to be used until the site isofficially registered.

6 For drug and biologics manufacturers: The mfrreport # is the number the manufacturer chooses touniquely identify the report, and should conform toany applicable regulations or guidances. For human cell, tissue, and cellular and tissue-based product (HCT/P) manufacturers: The reportnumber should consist of three numbers separatedby dashes. The first number will be the 10-digit FDAE stablishment Identifier (FEI) number, which wasassigned to you as part of the Human Cells andTissue Establishment Registration (HCTERS). Thesecond number should be the year that you aresubmitting the report. The last number should be aconsecutive 5-digit number for each report filed duringthe year by the manufacturer. Example: 1234567890-2016-00005 If submitting a follow-up to a report originally obtainedfrom FDA through a MedWatch to ManufacturerProgram, check the other box in block G3 and enterthe FDA-assigned report number report #: This is the unique identifier used by the user facility or the importer for this report.

7 For a follow-up report, the UF/Importer report number must be identical to the number assigned to the initial report. The UF/Importer report number is also entered in block F2 on the back of the form . The user facility report number consists of threecomponents: the facility s 10-digit Centers forMedicare & Medicaid Services (CMS) number, the4-digit calendar year, and a consecutive 4-digitnumber for each report filed during the year by thefacility ( , 1234567890-2016-0001, 1234567890-2016-0002). If the CMS number has fewer than10 digits, enter ONLY these numbers, leaving the remainder blank (zeros will be automatically filled in by the system). If a facility does not have a CMS number, the first report and any subsequent reports should be submitted with all zeros in the CMS space ( , 0000000000-2016-0001), and FDA will assign a number to be used in future reports. If a facility has more than one CMS number, the facility must select one of those numbers as the primary number and use it for subsequent submissions.

8 If a user facility has multiple sites, the primary site can report centrally and use one reporting number for all sites IF the primary site provides an addendum that identifies the name, address, and CMS number for the other sites. The importer report number consists of threecomponents: the FDA-assigned registration oridentification number for the importer of the device,the 4-digit calendar year, and a consecutive 5-digitnumber for each report filed during the year by theimporter ( , 1234567-2016-00001, 1234567-2016-00002). If an importer does not have an assignedidentification number, it should use all zeros in theappropriate space on the initial report, and continueto use zeros on subsequent reports until the FDA-assigned number is received. The importer would stillenter the 4-digit calendar year and 5-digit sequencenumber. Note: In cases where a reporting site is registeredas both a manufacturer and an importer, and theregistration and/or FDA-assigned identificationnumbers are identical for both, then the 5-digitsequence number for reports submitted during theyear by either one may NOT be duplicated.

9 Forexample, for devices manufactured by the firm,the report number would consist of the registrationnumber, calendar year, and a consecutive 5-digitnumber ( , 1234567-2016-00001, 1234567-2016-00002, and so on). For devices imported by the firm,the registration number and year would remain thesame, but the 5-digit sequence number must bedifferent ( , 1234567-2016-00003, 1234567-2016-00004, and so on). form FDA 3500A SUPPLEMENT (4/16) form instructions Page 2 of 15 SECTION A: PATIENT INFORMATION Complete a separate form for each patient. If you are a user facility reporting an event where multiple patients were adversely affected at the same time through the use of one device, you do not need to file a separate form FDA 3500A for each patient as long as you: Indicate the number of patients in block B5 (describeevent or problem). Prepare a complete form FDA 3500A for one patientand attach additional 3500As with section A andblocks B2, B5, B6, B7, D11, F2 and F10 filled in foreach additional patient [Be sure to identify all formswith the user facility report number].

10 Enter the corresponding patient identifier in block A1for each patient involved in the report(s) are those cases in which either a mother or a fetus/breast feeding infant, or both, sustain an adverse event that the initial reporter considers possibly associated with a product administered to or a device used on the mother during pregnancy. Several general principles are used for filing these reports: If the event did not affect the infant/fetus, report onlyon the mother For those cases describing fetal death, miscarriage orabortion, report the mother as the patient in the report. When ONLY the infant/fetus has an adverse reaction/event (other than fetal death, miscarriage or abortion),the information provided in section A applies to theinfant/fetus. However, the information in section C orD would apply to the mother who was the source ofexposure to the product or device. When a newborn baby is found to have a congenitalanomaly/birth defect that the initial reporter considerspossibly associated with a product administered toor device used on the mother during pregnancy, thepatient is the newborn baby.