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

Model Number PVPM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Hernia (2240); Anxiety (2328)

Event Type  Injury  

Manufacturer Narrative

(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form. In addition, a device history review has been inserted into the file. This review indicates that there was no quality concerns associated with the manufacturing process.

Event Description

It was reported by an attorney that the patient underwent umbilical hernia repair surgery on (b)(6) 2016 and mesh was implanted. It was reported that the patient underwent open repair of recurrent ventral hernia and removal surgery on (b)(6) 2017 during which, according to the records, ¿a large wad of mesh material was removed and sent for pathologic evaluation. ¿ it was reported that the patient experienced severe pain, hernia recurrence, removal surgery, inflammation, loss of appetite, stress and anxiety. No additional information is provided.

Manufacturer Narrative

Date sent to fda: 9/10/2020.

• 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 0151
• MDR Report Key: 8205634
• MDR Text Key: 131702170
• Report Number: 2210968-2018-77826
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K061533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 03/31/2018
• Device Model Number: PVPM
• Device Catalogue Number: PVPM
• Device Lot Number: KD8GQHB0
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 12/30/2018 Patient Sequence Number: 1