MAUDE Adverse Event Report: ETHICON INC. PVP MEDIUM 6.4CM X 6.4CM; MESH, SURGICAL, POLYMERIC

Model Number PVPM

Device Problem Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.

Event Description

It was reported that a patient underwent a ventral hernia repair procedure on (b)(6) 2020 and the mesh was implanted.It was reported that there was a defect in the seam of one of the anchoring straps.When the surgeon wants to fix the mesh, when pulling on the straps, the mesh moves and cannot stay in place.Another like device was used to successfully complete the procedure.There were no adverse patient consequences reported.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 11/20/2020.H3 evaluation: a mesh product and an empty opened foil of product were received for evaluation.During the visual inspection of mesh product body fluids, degradation and partially detachment wing could be observed.The foil packet was examined under magnification and several wrinkles and two pin holes were noted.This condition contributed to degradation of mesh product.No conclusion could be reached as on what caused the reported complaint.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PVP MEDIUM 6.4CM X 6.4CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10701503
• MDR Text Key: 212263677
• Report Number: 2210968-2020-08116
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031132405
• UDI-Public: 10705031132405
• Combination Product (y/n): N
• PMA/PMN Number: K061533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: PVPM
• Device Catalogue Number: PVPM
• Device Lot Number: PLBCKTB0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1