VESICA PERC STABILIZATION KIT WITH PROTEGEN SLING UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2002-09-25 for VESICA PERC STABILIZATION KIT WITH PROTEGEN SLING UNK manufactured by Boston Scientific Corp. / Microvasive Urology.

Event Text Entries

[18160761] The patient reported that subsequent to the implant of a protegen sling for treatment, they experienced pain, incontinence and frequent urinary tract infections. The patient reported they change their undergarments about two times per day. The patient did not report removal of the device. The device was not returned for evaluation. Therefore, no failure analysis is available. Without evaluating this device, company is unable to determine if the device met specifications, and company is unable to determine the specific relationship of the device to the event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6000043-2002-00171
MDR Report Key419117
Report Source04
Date Received2002-09-25
Date of Report2002-08-28
Date Reported to FDA2002-09-25
Date Mfgr Received2002-08-28
Date Added to Maude2002-10-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 G1MICROVASIVE UROLOGY
Manufacturer Street780 BROOKSIDE DRIVE
Manufacturer CitySPENCER IN 47460
Manufacturer CountryUS
Manufacturer Postal Code47460
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVESICA PERC STABILIZATION KIT WITH PROTEGEN SLING
Generic NamePERC STABILIZATION KIT
Product CodeFHK
Date Received2002-09-25
Model NumberNA
Catalog NumberUNK
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
Implant FlagY
Date RemovedU
Device Sequence No1
Device Event Key408162
ManufacturerBOSTON SCIENTIFIC CORP. / MICROVASIVE UROLOGY
Manufacturer Address780 BROOKSIDE DRIVE SPENCER IN 47460 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2002-09-25

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