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Adverse Event Report

ETHICON SARL A JOHNSON & JOHNSON COMPANY TENSION FREE VAGINAL TAPE TVT DEVICE   back to search results
Catalog Number 810041
Device Problem Implant extrusion
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

The patient underwent a sling procedure in 2002. Post-operatively, the patient presented with vaginal extrusion of the mesh. The physician excised the exposed area of the mesh.

 
Manufacturer Narrative

H6 conclusion: no conclusion can be drawn at this time. The product insert, which accompanies each device states that "transitory local irritation at the wound site and a transitory foreign response may occur. This response could result in extrusion, erosion, fistula formation and inflammation. ".

 
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Brand NameTENSION FREE VAGINAL TAPE
Type of DeviceTVT DEVICE
Baseline Brand NameTENSION FREE VAGINAL TAPE
Baseline Generic NameTVT DEVICE
Baseline Catalogue Number810041
Baseline Device 510(K) Number
Baseline Device PMA Number
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
mark yale
route 22 west
p.o. box 151
somerville , NJ 08876-0151
(908) 218 -2326
Device Event Key431765
MDR Report Key442789
Event Key419137
Report Number2210968-2003-00067
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Physician
Type of Report Initial
Report Date 01/15/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/13/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number810041
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Ageunknown
Event Location Hospital
Date Manufacturer Received01/15/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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 February 28, 2009

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