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); Inflammation (1932); Pain (1994)

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 incisional hernia repair surgery on (b)(6) 2012 and mesh was implanted.It was reported that the patient underwent removal and incisional hernia repair surgery on (b)(6) 2012 during which the surgeon noted ¿there was bowel adhered to the mesh.There was omentum adherent to the old mesh as well and laparoscopic lysis of adhesions was undertaken.The mesh itself was bunched in the midline, allowing the lateral aspect of the hernia defect to be exposed.Once this was discovered, the mesh was removed using laparoscopic shears as well as blunt dissection.This mesh was completely removed.¿ it was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.No additional information is provided.

Manufacturer Narrative

Date sent to fda: 10/9/2020.

• 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: 8193208
• MDR Text Key: 131304535
• Report Number: 2210968-2018-77695
• 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
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVPM
• Device Catalogue Number: PVPM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention