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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Rheumatoid Arthritis (1724); Nerve Damage (1979); Pain (1994); Ambulation Difficulties (2544); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent an unknown procedure in (b)(6) 2012 and mesh was implanted. The patient reported that there were no incontinence issues for six months, however, she did experience pain down the legs which was managed with paracetamol and ibruphen for about a year and half. The patient reported that she had also experienced fibro fog, fibromyalgia, inflammatory rheumatoid arthritis, chronic fatigue, dysfunctional movement disorder, chronic pain, nerve damage in legs and overall decrease in quality of life. The patient went to the hospital in 2015 and 2016. No additional information is available.

• Brand Name: GYNECARE MESH UNKNOWN
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7506524
• MDR Text Key: 108008058
• Report Number: 2210968-2018-72728
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/11/2018 Patient Sequence Number: 1