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

Model Number	810041A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Urethral Stenosis/Stricture (4501); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 the patient underwent revision surgery on (b)(6) 2021.It was reported that the patient experienced an undisclosed adverse event.No additional information was provided.
Additional Manufacturer Narrative
Date sent to the fda: 6/28/2022.Additional information: d4, h4.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
Additional Manufacturer Narrative
Date sent to the fda: 6/12/2022.Additional information: a1, a2, d1, d4, g4.Additional b5 narrative: it was reported that the patient experience urethral mesh erosion, vaginal mesh erosion, urethral stricture and stenosis.

• Brand Name: GYNECARE TVT W/ABDOMINAL
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14191451
• Report Number: 2210968-2022-02912
• Device Sequence Number: 11882599
• Product Code: OTN
• UDI-Device Identifier: 10705031062283
• UDI-Public: 10705031062283
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K012628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/24/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2009
• Device Model Number: 810041A
• Device Catalogue Number: 810041A
• Device Lot Number: 2969652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 06/10/2022; 06/27/2022; 04/04/2023
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 06/12/2022; 06/28/2022; 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2006
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female