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

Catalog Number TVTS4

Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problems Erosion (1750); Pain (1994); No Code Available (3191)

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) 2007 and mesh was implanted.It was reported that she experienced undisclosed injuries.No additional information was provided.

Manufacturer Narrative

It was reported that the patient underwent a gynecological surgical procedure on (b)(6)2007 and tvts was implanted.No additional information was provided.In addition, a device history review has been inserted into the file.This review indicates that there was no quality concerns associated with the manufacturing process.

Manufacturer Narrative

Date sent to fda: 06/24/2019.

Manufacturer Narrative

Date sent to the fda: 12/13/2020.Additional narrative: it was reported that the patient experienced pain and erosion of her internal bodily tissues.It was reported that the patient has undergone multiple surgeries and revisionary procedures.

• Brand Name: GYNECARE TVT SECUR -TENSION-
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: jane kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 6841362
• MDR Text Key: 84633422
• Report Number: 2210968-2017-70108
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2008
• Device Catalogue Number: TVTS4
• Device Lot Number: 2978200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2020
• Date Device Manufactured: 11/20/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR