MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT ABREVO CONTINENCE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number TVTOML

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported that the patient underwent an unknown gynecological procedure on (b)(6) 2015 and mesh was implanted.During the procedure, the plastic tip was bent on the tip of the mesh.Another like device was used to complete the procedure.There were no patient consequences reported.Additional information has been requested.

Manufacturer Narrative

(b)(4): to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.This report is a 30 day initial report, sent as follow-up 1 due to emdr duplicate error.

Event Description

It was reported that the patient underwent an unknown gynecological procedure on (b)(6) 2015 and mesh was implanted.During the procedure, the plastic tip was bent on the tip of the mesh.Another like device was used to complete the procedure.There were no patient consequences reported.Additional information has been requested.

• Brand Name: GYNECARE TVT ABREVO CONTINENCE SYSTEM
• 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 2000 neuchatel; neuchatel ; SZ
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5341125
• MDR Text Key: 34964101
• Report Number: 2210968-2016-00022
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2015

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: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: TVTOML
• Device Lot Number: 3830277
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/17/2015
• Initial Date FDA Received: 01/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/17/2015
• 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