820-121

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-03-10 for 820-121 manufactured by Microvasive Urology.

Event Text Entries

[20996900] It was reported that subsequent to the implant of a protegen sling for treatment of urinary incontinence, symptoms returned and the device was explanted. The device was not returned for eval. Therefore, no failure analysis is available. Without evaluating this device, co was unable to determine if the device met specs, and co was unable to determine the specific relationship of the device to the event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6000043-2003-00022
MDR Report Key448439
Report Source05,06
Date Received2003-03-10
Date of Report2003-02-11
Date of Event2000-11-14
Date Reported to FDA2003-03-10
Date Mfgr Received2003-02-11
Device Manufacturer Date1997-08-01
Date Added to Maude2003-03-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactNANCY MICHAUD
Manufacturer StreetONE BOSTON SCIENTIFIC PLACE
Manufacturer CityNATICK MA 01760153
Manufacturer CountryUS
Manufacturer Postal01760153
Manufacturer Phone5086508349
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NamePUBOVAGINAL SLING
Product CodeFHK
Date Received2003-03-10
Model NumberNA
Catalog Number820-121
Lot Number167127
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
Implant FlagY
Date RemovedV
Device Sequence No1
Device Event Key437417
ManufacturerMICROVASIVE UROLOGY
Manufacturer Address780 BROOKSIDE DRIVE SPENCER IN 47460 US
Baseline Brand NameVESICA PERC STABILIZATION KIT W/ PROTEGEN SLING
Baseline Generic NamePERC STABILIZATION KIT
Baseline Model NoNA
Baseline Catalog No820-121
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2003-03-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.