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 Nausea (1970); Pain (1994); Chills (2191)

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 recurrent hernia repair surgery and appendicitis surgery on (b)(6) 2020 during which the surgeon noted feculent fluid in the right abdomen resulting from omental adhesions to the previous midline umbilical mesh.He excised the retracted previous mesh that had essentially formed a hard ball in the infra-umbilical peritoneum in a piecemeal fashion; freed the intraabdominal omental adhesion, evacuated peritoneal and interloop feculent abscess pockets.The cecum had become markedly distended, perforated and involving a 7.5 cm hemorrhagic firm mass of severe inflamed and gangrenous appendix.He performed a right hemicolectomy, resecting the injured intestine including segment of terminal ileum, cecum, appendix and 13.5 cm of ascending colon.It was reported that the patient experienced severe pain, nausea, chills, inflammation, bowel injuries, loss of appetite and discomfort.No additional information was provided.

Manufacturer Narrative

Date sent to the fda.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: 5/25/2021.Additional b5 narrative: it was reported that the patient underwent removal surgery on (b)(6) 2020.

• Brand Name: PVP MEDIUM 6.4CM X 6.4CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11490512
• MDR Text Key: 247035031
• Report Number: 2210968-2021-02357
• 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: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2012
• Device Model Number: PVPM
• Device Catalogue Number: PVPM
• Device Lot Number: DL8BZDZ0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention