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

Catalog Number PHY1015V

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

Patient Problems Adhesion(s) (1695); Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Hernia (2240); Discomfort (2330); Weight Changes (2607); Decreased Appetite (4569)

Event Type  Injury  

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) 2019 due to adhesions and bowel adherence.The surgeon then repaired the defect with an additional piece of (unknown) hernia mesh.It was reported the patient experienced pain, nausea, diarrhea, chills, inflammation, loss of appetite, and weight loss.No additional information was provided.

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.

Manufacturer Narrative

Date sent to the fda: 10/27/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Date sent to the fda: 10/27/2021 corrected information: d6a.Corrected b5 narrative: it was reported that the patient underwent hernia repair surgery on (b)(6) 2013 and mesh was implanted.

Manufacturer Narrative

Date sent to the fda: 4/7/2022.It was reported that the patient experienced recurrent ventral hernia and discomfort following surgery.

• Brand Name: PHYSIOMESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12662730
• MDR Text Key: 284360163
• Report Number: 2210968-2021-09993
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Catalogue Number: PHY1015V
• Device Lot Number: EH8KWSA0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male