MAUDE Adverse Event Report: ETHICON INC. PVP SMALL 4.3CM X 4.3CM; MESH, SURGICAL, POLYMERIC

Model Number PVPS

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

Patient Problems Abscess (1690); Necrosis (1971); Not Applicable (3189)

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.Mwr-04122019-0000615304 submitted for adverse event which occurred on (b)(6) 2017.Mwr-26082020-0000792992 submitted for adverse event which occurred on (b)(6) 2017.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2015 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2017 during which the surgeon noted there was significant adhesions to the abdominal wall with multiple ventral hernias and that the mesh was the source of the chronic infection.It was reported that the patient experienced severe pain, nausea, inflammation, bulging, stress and anxiety.It was reported that the patient underwent abdominal wall abscess with debridement of necrotic tissue on (b)(6) 2017.No additional information is provided.

Manufacturer Narrative

A review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.

• Brand Name: PVP SMALL 4.3CM X 4.3CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10460435
• MDR Text Key: 204580554
• Report Number: 2210968-2020-06400
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031132412
• UDI-Public: 10705031132412
• 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: 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: 11/30/2015
• Device Model Number: PVPS
• Device Catalogue Number: PVPS
• Device Lot Number: HP8DMZZ0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention