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Adverse Event Report

BALLYMONEY - USS IVS TUNNELLER SURGICAL MESH   back to search results
Catalog Number IVS02
Event Date 01/31/2003
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Post-op vaginal erosion was noted in 2004. The surgeon removed the sling, no replacement. Procedure: ivs tunneller for stress urinary incontinence.

 
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Brand NameIVS TUNNELLER
Type of DeviceSURGICAL MESH
Baseline Brand NameIVS TUNNELLER
Baseline Generic NameSURGICAL MESH
Baseline Catalogue NumberIVS02
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BALLYMONEY - USS
20 garryduff road
antrim
IRELAND BT53 7AP
Manufacturer (Section D)
BALLYMONEY - USS
20 garryduff road
antrim
IRELAND BT53 7AP
Manufacturer (Section G)
BALLYMONEY - USS
20 garryduff road
ballmoney co, antrim
IRELAND BT53
Manufacturer Contact
jeff deming
195 mcdermont rd
north haven , CT 06473
(203) 492 -6049
Device Event Key531932
MDR Report Key542564
Event Key515256
Report Number6000141-2004-00008
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Other
Type of Report Initial
Report Date 08/09/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/07/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberIVS02
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/09/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
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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