MAUDE Adverse Event Report: ETHICON SARL GYNECARE TVT EXACT CONTINENCE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number TVTRL

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date, the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent an unknown procedure on an unknown date and mesh was implanted.During use, the metal introduced punctured the white plastic sheath of the device.There were no adverse patient consequences.No additional information was provided.

Manufacturer Narrative

The device received was manipulated and used.A plastic needle was bent.Based on the evaluation, this complaint is not a manufacturing issue.

Manufacturer Narrative

It was reported that the patient underwent an unknown procedure on (b)(6) 2016 and mesh was implanted.During use, the metal introduced punctured the white plastic sheath of the device.There were no adverse patient consequences.No additional information was provided.

• Brand Name: GYNECARE TVT EXACT CONTINENCE SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON SARL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6125150
• MDR Text Key: 60868328
• Report Number: 2210968-2016-36112
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TVTRL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention