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

Model Number 810081L

Device Problem Migration (4003)

Patient Problems Incontinence (1928); Pain (1994); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgery on (b)(6) 2009 and two mesh were implanted.It was reported that the patient underwent concurrent vaginal hysterectomy and bilateral salpingo-oophorectomy procedure.It was reported that following insertion the patient experienced incomplete bladder emptying, vaginal atrophy, pelvic pain, incontinence and bladder muscle dysfunction.It was reported that the patient underwent excision of mesh on (b)(6) 2017 due to urethral obstruction and mesh erosion.No additional information was provided.

Manufacturer Narrative

Date sent to fda: 10/13/2020.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: GYNECARE TVT OBTURATOR W LASR
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10648154
• MDR Text Key: 210375419
• Report Number: 2210968-2020-07725
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: 10705031062306
• Combination Product (y/n): N
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2010
• Device Model Number: 810081L
• Device Catalogue Number: 810081L
• Device Lot Number: 3308256
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention