MAUDE Adverse Event Report: ETHICON, INC. GYNECARE TVT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET

Model Number 810041B

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2017

Event Type  malfunction  

Event Description

Ethicon gynecare tvt (transvaginal tape) would not function properly.Manufacturer response for gynecare tvt, (per site reporter).They will call them into the company and send replacement product.

• Brand Name: GYNECARE TVT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET
• Manufacturer (Section D): ETHICON, INC.; route 22 west; p. o. box 151; somerville NJ 08876
• MDR Report Key: 7211781
• MDR Text Key: 97969774
• Report Number: 7211781
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2020
• Device Model Number: 810041B
• Device Catalogue Number: 810041B
• Device Lot Number: 3911441, 3929826
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1