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

Catalog Number 810041

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Fistula (1862); Hematoma (1884); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Seroma (2069); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

This emdr represents supplemental report # (b)(4) for previously submitted mdr number 2210968-2018-76760, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation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.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2003 and tvt was implanted.It was reported that the patient experienced infection, bleeding, fistula, abscess, hematoma, seroma, swelling and recurrent stress urinary incontinence.It was reported that the patient underwent revision surgery on (b)(6) 2012.No additional information was provided.

• Brand Name: TVT DEVICE WITH PROLENE TAPE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12697532
• MDR Text Key: 281273097
• Report Number: 2210968-2021-10228
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 10/26/2021

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: 11/30/2007
• Device Catalogue Number: 810041
• Device Lot Number: 1061012
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR