MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH 15X15CM; MESH, SURGICAL, POLYMERIC

Catalog Number PMM3

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Evaluation: pictures were received for evaluation and the following was observed.Upon to visual inspection of picture 1 & 2 showed an overwrap packet, re-labeled with product code, lot number and expiration date.The lot number was entered in our system and the lot number was found.The batch expiration date on the label in the image does not match what is in our system, therefore it is concluded that it is a confirmed counterfeit.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that an ethicon product was suspected to be a counterfeit device on (b)(6) 2020 and the mesh was involved.Upon evaluation of the returned photo the device was confirmed to be a counterfeit.There was no patient involvement reported.

• Brand Name: PROLENE MESH 15X15CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10693179
• MDR Text Key: 211936927
• Report Number: 2210968-2020-08087
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: PK
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: PMM3
• Device Lot Number: LHH787
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1