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

Catalog Number PHY2025V

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Unspecified Infection (1930); Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

To date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500 form.

Event Description

It was reported by an attorney that the patient underwent a laparoscopic ventral hernia repair on (b)(6) 2011 and mesh was implanted.Post-operatively it was reported that the patient experienced persistent abdominal pain, dysuria, and recurrent urinary tract infections.  on (b)(6) 2014 the patient was admitted to (b)(6) hospital in (b)(6) for recurrent urinary tract infections and dysuria.Dr.(b)(6) surveyed the patient¿s  bladder and found that the mesh had eroded into her bladder.Dr.(b)(6) found and removed a ¿foreign body greenish in hue¿ at the dome of her bladder and ¿what appeared to be an epithelialized band of bladder mucosa¿ from her bladder.On (b)(6) 2016 the patient was admitted to (b)(6) medical center, (b)(6) hospital in (b)(6) to remove the mesh that was infected and had eroded into her bladder and to treat the vesicocutaneous fistula that formed as a result of the defective mesh device.No additional information was provided.

Manufacturer Narrative

Date sent to fda: 7/4/2019.

Manufacturer Narrative

Date sent to fda: 12/17/2019.In addition, a review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.

• Brand Name: PHYSIOMESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.-GMBH; p.o box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville 08876-0151 ; 6107428552
• MDR Report Key: 7155686
• MDR Text Key: 96108528
• Report Number: 2210968-2017-72042
• 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,Followup
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: PHY2025V
• Device Lot Number: DE8HXCA0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2019
• Date Device Manufactured: 05/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 106