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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVASIVE BOSTON SCIENTIFICPROTOGEN SLING

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MICROVASIVE BOSTON SCIENTIFIC PROTOGEN SLING   Back to Search Results
Device Problem Implant, removal of
Event Date 09/07/2001
Event Type  Malfunction   Patient Outcome  Other
Event Description

Protogen sling implanted at surgery center. Pt experienced recurrent urinary tract infections for greater than 1 and 1/2 years status post protogen sling implant. Cystoscopy done - normal protogen sling removed due to recurrent urinary tract infections.

 
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Brand NamePROTOGEN SLING
Type of DevicePROTOGEN SLING
Manufacturer (Section F)
MICROVASIVE BOSTON SCIENTIFIC
480 pleasant st
watertown MA 02172
Manufacturer (Section D)
MICROVASIVE BOSTON SCIENTIFIC
480 pleasant st
watertown MA 02172
Device Event Key342909
MDR Report Key353693
Event Key333238
Report Number353693
Device Sequence Number1
Product CodeFHK
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/14/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/17/2001
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/14/2001
Distributor Facility Aware Date09/07/2001
Event Location Hospital
Date Report TO Manufacturer09/14/2001
Is the Device an Implant? Yes
Is this an Explanted Device?

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