SPARC SLING SYSTEM * NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-07-12 for SPARC SLING SYSTEM * NA manufactured by American Medical Systems, Inc..

Event Text Entries

[250538] Doctor stated patient had mesh erosion. Lot/serial number not indicated. No further information has been provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183959-2002-00040
MDR Report Key404925
Report Source05
Date Received2002-07-12
Date of Report2002-07-11
Date Mfgr Received2002-06-11
Date Added to Maude2002-07-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTHERESE BOWKER, MDR CONTACT
Manufacturer Street10700 BREN ROAD WEST
Manufacturer CityMINNETONKA MN 55343
Manufacturer CountryUS
Manufacturer Postal55343
Manufacturer Phone9529306624
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPARC SLING SYSTEM
Generic NameSPARC SLING SYSTEM
Product CodeFHK
Date Received2002-07-12
Model Number*
Catalog NumberNA
Lot NumberNI
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key393923
ManufacturerAMERICAN MEDICAL SYSTEMS, INC.
Manufacturer Address10700 BREN RD., WEST MINNETONKA MN 55343 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2002-07-12

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