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

Catalog Number PVPM

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

Patient Problems Unspecified Infection (1930); Pain (1994); Burning Sensation (2146)

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) 2012 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2015 during which the surgeon noted a large hernia sac almost 6x6 cm which appeared to have old mesh in it.It was dissected out.After excising the previous sutures, the retroperitoneal tissues were dissected out.It was reported that the patient experienced severe pain, burning and mrsa.No additional information is provided.

Manufacturer Narrative

Date sent to the fda: 3/29/2021.Additional information: a2, b7.

Manufacturer Narrative

Date sent to the fda: 05/25/2021.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: 4/6/2021.Corrected information: g1 - manufacturing site name and address.

• 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: 10402712
• MDR Text Key: 202862475
• Report Number: 2210968-2020-06084
• 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,Followup,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2012
• Device Catalogue Number: PVPM
• Device Lot Number: EA8JHXZ0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR