URINAL * 8601

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-13 for URINAL * 8601 manufactured by Lsl Industries, Inc..

Event Text Entries

[16912398] The nurse noted urine leaking from the urinals. She noted this two separate times. Both urinals were discarded. No other issues noted with any other urinals on this floor and any other floors.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3364021
MDR Report Key3364021
Date Received2013-09-13
Date of Report2013-07-29
Date of Event2013-07-11
Report Date2013-07-29
Date Reported to FDA2013-09-13
Date Reported to Mfgr2013-09-24
Date Added to Maude2013-09-24
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 NameURINAL
Generic NameURINAL
Product CodeFNP
Date Received2013-09-13
Model Number*
Catalog Number8601
Lot Number*
ID Number*
OperatorPATIENT
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerLSL INDUSTRIES, INC.
Manufacturer Address5535 N. WOLCOTT AVE CHICAGO IL 60640 US 60640


Patients

Patient NumberTreatmentOutcomeDate
10 2013-09-13

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