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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Pain (1994)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on an unknown date and mesh was implanted. It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure. It was reported that the patient has undergone multiple surgeries and revisionary procedures. The patient had had a previous mesh implanted on (b)(6) 2007 which is captured in separate file. 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.

• 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.-SOMERVILLE; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13756815
• Report Number: 2210968-2022-01761
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• 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?: No
• Date Manufacturer Received: 11/16/2022
• 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?: No
• Type of Device Usage: Initial
• Patient Sex: Female
• Patient Weight: KG
• Patient Outcome(s): Required Intervention