PROTEGEN SLING * 820-121

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-03-10 for PROTEGEN SLING * 820-121 manufactured by Boston Scientific.

Event Text Entries

[20770897] Protegen transvaginal sling placed in 1998 for urinary incontinence. Symptoms returned. Product removed in 2000.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number448434
MDR Report Key448434
Date Received2003-03-10
Date of Report2003-01-24
Date of Event2000-11-14
Date Added to Maude2003-03-19
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePROTEGEN SLING
Generic NameTRANSVAGINAL SLING GRAFT
Product CodeFHK
Date Received2003-03-10
Model Number*
Catalog Number820-121
Lot Number167127
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age*
Implant FlagY
Date RemovedV
Device Sequence No1
Device Event Key437417
ManufacturerBOSTON SCIENTIFIC
Manufacturer AddressP.O. BOX 951653 DALLAS TX 75395 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. Other 2003-03-10

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