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 2002-12-30 for VESICA PERC STABILIZATION KIT WITH PROTEGEN SLING UNK manufactured by Microvasive Urology, A Div Of Boston Scientific Corp..

Event Text Entries

[277844] The pt reported that subsequent to the implant of a protegen sling for treatment, physician found a synthetic suture material hanging from pt's urethral meatus approx 6cm long. The physician further found during a cystoscopy procedure the sling had eroded into the posterior wall of the urethra with suture material extending from this out of the urethra. The sling was removed and reconstructive surgery was performed. The device was not returned for evaluation. Therefore, no failure analysis is available. Without evaluating this device, co was unable to determine if the device met specifications, 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 Number6000043-2002-00203
MDR Report Key435480
Report Source04
Date Received2002-12-30
Date of Report2002-12-02
Date of Event2002-01-25
Date Reported to FDA2002-12-30
Date Mfgr Received2002-12-02
Date Added to Maude2003-01-03
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 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

Brand NameVESICA PERC STABILIZATION KIT WITH PROTEGEN SLING
Generic NamePERC STABILIZATION KIT
Product CodeFHK
Date Received2002-12-30
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 Key424399
ManufacturerMICROVASIVE UROLOGY, A DIV OF BOSTON SCIENTIFIC CORP.
Manufacturer Address780 BROOKSIDE DRIVE SPENCER IN 47460 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2002-12-30

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