CYSTOFLO II URINARY DRAINAGE BAG * 2D2577V

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-23 for CYSTOFLO II URINARY DRAINAGE BAG * 2D2577V manufactured by Baxter Healthcare Corp. Renal Div..

Event Text Entries

[37578] Pt reports last 3 urinary bags leak near clamp location.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1010450
MDR Report Key57606
Date Received1996-12-23
Date of Report1996-12-20
Date of Event1996-10-20
Date Added to Maude1996-12-26
Event Key0
Report Source CodeVoluntary 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 FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCYSTOFLO II URINARY DRAINAGE BAG
Generic NameURINARY DRAINAGE BAG
Product CodeEYZ
Date Received1996-12-23
Model Number*
Catalog Number2D2577V
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key58096
ManufacturerBAXTER HEALTHCARE CORP. RENAL DIV.
Manufacturer Address1620 WAUKEGAN RD MCGAW PARK IL 600856730 US


Patients

Patient NumberTreatmentOutcomeDate
10 1996-12-23

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