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 Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Weight Changes (2607); Decreased Appetite (4569)

Event Type  Injury  

Manufacturer Narrative

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 removal and recurrent hernia repair surgery on (b)(6) 2020 and mesh was implanted during which the surgeon noted that the mesh was tightly adherent to the bowel underneath.After extensive and tedious lysis of adhesions, he was able to dissect the mesh of the bowel and remove the mesh.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.The patient had a previous mesh implanted on (b)(6) 2016 which is captured in separate file.No additional information was provided.

• Brand Name: PVP SMALL 4.3CM X 4.3CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12694692
• MDR Text Key: 284618814
• Report Number: 2210968-2021-10291
• 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
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVPS
• Device Catalogue Number: PVPS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention