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

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

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 03/17/2010

Event Type  Injury  

Event Description

It was reported that a patient underwent an anterior gynecological procedure on (b)(6) 2010 and the mesh was implanted.It was reported that the patient experienced pelvic pain, lower back pain, pain over buttocks and pubic bone, difficulty standing straight, and incomplete emptying of bladder.

Manufacturer Narrative

(b)(4).If further details are received at a later date a supplemental medwatch will be sent.

• Brand Name: GYNECARE MESH UNKNOWN
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12728490
• MDR Text Key: 284630464
• Report Number: 2210968-2021-10663
• 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: foreign,other
• Type of Report: Initial
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2021
• Patient Sequence Number: 1