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Adverse Event Report

ETHICON SARL A JOHNSON & JOHNSON COMPANY TENSON FREE VAGINAL TAPE TVT DEVICE   back to search results
Catalog Number 810041
Device Problem Needle, separation
Event Date 04/29/2002
Event Type  Malfunction  
Event Description

It was reported that during a bladder suspension procedure, the tape detached from the needle. There were no patient consequences reported.

 
Manufacturer Narrative

This is one of two medwatch reports being submitted as two separate devices were used during this case. The same patient is represented in each medwatch form. H-6 conclusion: three actual samples was returned for evaluation. The shrink tube/mesh assembly has come off three of the six needles.

 
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Brand NameTENSON FREE VAGINAL TAPE
Type of DeviceTVT DEVICE
Baseline Brand NameTENSION FREE VAGINAL TAPE
Baseline Generic NameTVT DEVICE
Baseline Catalogue Number810041
Baseline Device FamilyTENSION FREE VAGINAL TAPE
Baseline Device 510(K) NumberK974098
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed10/06/1998
Manufacturer (Section F)
ETHICON SARL A JOHNSON & JOHNSON COMPANY
rue du puits godet 20
neuchatel
SWITZERLAND 2000
Manufacturer (Section D)
ETHICON SARL A JOHNSON & JOHNSON COMPANY
rue du puits godet 20
neuchatel
SWITZERLAND 2000
Manufacturer Contact
rita mcintyre
route 22 west
p.o. box 151
somerville , NJ 08876-0151
(908) 218 -2398
Device Event Key386774
MDR Report Key397727
Event Key375816
Report Number2210968-2002-00445
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 05/01/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/31/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number810041
Device LOT Number881525
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/14/2002
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/29/2002
Device Ageunknown
Event Location Hospital
Date Manufacturer Received05/01/2002
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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