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 Adhesion(s) (1695); Nausea (1970); Weakness (2145); Hernia (2240); Obstruction/Occlusion (2422)

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.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2010 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2012 during which the surgeon noted the mesh was obvious and had contracted into a ball.It appeared as tough this had pulled away from the lateral aspect of the repair causing either recurrent hernia or at least an area of weakness at this site.The mesh was excised with sharp scissors.It was reported that the patient experienced severe pain, nausea and stomach issues.No additional information is provided.

Manufacturer Narrative

Date sent to fda: 9/2/2020.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

Date sent to the fda: 1/18/2021.Additional information: a1, a2, b7.Additional b5 narrative: it was reported that the patient experienced adhesions and intestinal blockage following surgery.

• 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: 10459725
• MDR Text Key: 204549309
• Report Number: 2210968-2020-06409
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2010
• Device Model Number: PVPM
• Device Catalogue Number: PVPM
• Device Lot Number: BM8HWLZ0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR