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

Lot Number XBP762

Device Problem Migration (4003)

Patient Problem Erosion (1750)

Event Date 03/29/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(b)(4).Device not returned.No additional information is available.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that a patient underwent an abdominal sacral hysteropexy on (b)(6) 2006 and the mesh was implanted.It was reported that the patient had mesh exposure excised on (b)(6) 2021.

• 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: 11939969
• MDR Text Key: 256089638
• Report Number: 2210968-2021-05275
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2011
• Device Lot Number: XBP762
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 06/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2006
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention