MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN MESH, SURGICAL

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

Patient Problems Arthritis (1723); Incontinence (1928); Pain (1994); Rash (2033); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4). Attempts are being made to obtain the following information.  to date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form attached.  .

Event Description

It was reported that a patient underwent a gynecological procedure on an unknown date in 2003 and the mesh was implanted. It was reported that the patient had many issues since the mesh was implanted in 2003, including double incontinence, ibs, arthritis, pains all over the body, and rashes. It was also reported that sitting down was painful for the patient and a cushion was required. It was also reported that the patient couldn't sleep at night because of the pain. It was reported that once the mesh was removed (it was doubled in half, sandwiched between the bowel and bladder) the patient became continent again. The patient's arthritis has improved, and the patient no longer seems to have ibs. It was reported that the mesh was removed on (b)(6) 2020. Additional information was requested.

• Brand Name: GYNECARE MESH UNKNOWN
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo 00754 ; 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11682033
• MDR Text Key: 261746333
• Report Number: 2210968-2021-03467
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/16/2021 Patient Sequence Number: 1