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

Model Number 810081

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Injury (2348); Blood Loss (2597)

Event Type  Injury  

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.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2013 and mesh was implanted.It was reported that the patient experienced undisclosed adverse event.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 8/28/2020.

Manufacturer Narrative

Date sent to fda: 07/03/2020.Additional information: a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

Date sent to the fda: 8/28/2020.Additional h6 patient code: 1750, 1928, 1930, 3189 - surgical intervention, 3191 - fecal hyperlucency, hyperactive bladder.Additional b5 narrative: it was reported that the patient experienced mesh erosion, pelvic pain, bleeding, infection, persistent urinary incontinence, fecal hyperlucency, pelvic floor muscle spasms and hyperactive bladder following surgery.It was reported that the patient underwent mesh removal on (b)(6) 2019.

• Brand Name: GYNECARE TVT OBTURATOR
• 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: 10215423
• MDR Text Key: 199464199
• Report Number: 2210968-2020-04922
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: 10705031000346
• 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,Followup,Followup
• Report Date: 06/29/2020

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: 04/30/2014
• Device Model Number: 810081
• Device Catalogue Number: 810081
• Device Lot Number: 3702886
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 06/30/2020
• Supplement Dates Manufacturer Received: 07/03/2020; 08/28/2020; 08/28/2020
• Supplement Dates FDA Received: 07/03/2020; 08/28/2020; 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 84