UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-06 for UNKNOWN manufactured by Unknown.

Event Text Entries

[2326395] On or about (b)(6) 2011, while a pt in the bone marrow transplant unit of (b)(6), i suffered a cut near the tip of my penis, from the sharp edge on the molded plastic urinal material through which insertion is required. I bled profusely, and blood was reported in my urine. Thanks to frequent urinations and the fact that i was being given antibiotics for infection of undetermined origin, the bleeding stopped within 24 hours, and the cut itself healed without becoming infected. I was discharged from the hospital on (b)(6). Prior to discharge, one of the nurses searched the supply room and provided a replacement urinal which she thought had a somewhat less sharp edge. Her supervisor indicated that she was writing a complaint report about the sharp edged urinals. Subsequent to returning home, i visited the nearest (b)(4) pharmacy and examined their type of urinals of similar but equivalent design. Theirs also had the same sharp edge. So this appears to be a generic problem associated with manufacturing processes of the class 2 plastic material. I conclude that this is an unsafe design, associated with lid retention, which should be subject to recall or removal from the market. Is there no standard or design requirement for these devices that would result in a rounded corner on the hole through which human flesh must be inserted?
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5022118
MDR Report Key2240766
Date Received2011-09-06
Date of Report2011-08-29
Date of Event2011-08-09
Date Added to Maude2011-09-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN
Generic NameDISPOSABLE URINAL - MALE, W/LID
Product CodeFNP
Date Received2011-09-06
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN
Manufacturer AddressUNKNOWN UNKNOWN


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other 2011-09-06

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