MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT DEVICE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 810041B

Device Problem Migration (4003)

Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758); Pain (1994); Hematuria (2558); Not Applicable (3189)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.This medwatch report is in response to receipt of maude event report mw5086250-1.

Event Description

It was reported that the patient underwent a gynecological procedure on unknown date and the mesh was implanted.The patient experienced blood in urine with severe abdominal pain.Initial diagnosis was a bladder stone, and the patient was referred to the urologist.After cystoscopy and surgery, it was discovered the mesh infiltrated the bladder which allows calculi to grow on it.The patient underwent a first interventional surgery since 2018.

Manufacturer Narrative

The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.

• Brand Name: GYNECARE TVT DEVICE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8725551
• MDR Text Key: 148922618
• Report Number: 2210968-2019-83132
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000322
• UDI-Public: 10705031000322
• Combination Product (y/n): N
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: 810041B
• Device Lot Number: 3732905
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention