MAUDE Adverse Event Report: ETHICON INC. ETHICON PHYSIOMESH OPEN; MESH, SURGICAL

Catalog Number OPHY1215

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

Patient Problems Adhesion(s) (1695); Nausea (1970); Pain (1994)

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 recurrent hernia repair surgery on (b)(6) 2016 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2017 during which the surgeon noted the small bowel and the transverse colon was densely adherent to the surface of the mesh within the peritoneal cavity.Dissection was very tedious and in order to clear the entire abdominal wall, lysis of adhesions took approximately 4 hours.It was reported 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) 2015 which is captured in separate file.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 08/17/2021.

Manufacturer Narrative

Date sent to the fda: 08/23/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: ETHICON PHYSIOMESH OPEN
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11467787
• MDR Text Key: 239467103
• Report Number: 2210968-2021-02283
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K141560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: OPHY1215
• Device Lot Number: JE8DCGA0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention