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

Model Number 810081L

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

Patient Problems Fatigue (1849); Micturition Urgency (1871); Incontinence (1928); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Date sent to fda: 8/5/2021.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 an unk date and mesh was implanted.It was reported that the patient experienced severe pain affecting daily activities, urge incontinence, fatigue, and painful sex.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 08/06/2021.Additional b5 narrative: it was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2014 and the mesh was implanted.

Manufacturer Narrative

Date sent to the fda: 8/11/2021.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.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12285444
• MDR Text Key: 265567636
• Report Number: 2210968-2021-07061
• 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: foreign,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/03/2021

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: 05/31/2015
• Device Model Number: 810081L
• Device Catalogue Number: 810081L
• Device Lot Number: 3785839
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/05/2021
• Supplement Dates Manufacturer Received: 08/05/2021; 08/11/2021; 08/13/2021
• Supplement Dates FDA Received: 08/06/2021; 08/11/2021; 08/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1