MAUDE Adverse Event Report: ETHICON INC. TVT EXACT RETROPUBIC SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number TVTRL

Device Problem Migration (4003)

Patient Problems Erosion (1750); Urinary Frequency (2275); Blood Loss (2597)

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 surgical procedure on (b)(6) 2017 and mesh was implanted.It was reported that the patient experienced urinary incontinence, urinary frequency, dyspareunia, cramping, bleeding, pain and mesh exposure.It was reported that the patient underwent revision surgery on (b)(6) 2020.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 6/14/2021.

Manufacturer Narrative

Date sent to the fda: 09/17/2021.

Manufacturer Narrative

Date sent to the fda: 10/06/2021.Additional information: d4, h4.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: TVT EXACT RETROPUBIC SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 10409687
• MDR Text Key: 203128151
• Report Number: 2210968-2020-06115
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K132054
• 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: 08/13/2020

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: 11/30/2021
• Device Catalogue Number: TVTRL
• Device Lot Number: 3938109
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 06/14/2021; 09/15/2021; 10/01/2021
• Supplement Dates FDA Received: 06/14/2021; 09/17/2021; 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention