FDA.reportPublic FDA data

MAUDE MDR 653501

MDR report key
653501
Report number
653501
Event key
0
Event type
3
Date of event
2005-12-05
Date received
2005-12-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1*MALE URINALMEDEGENFNP*H140D01*N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-12-060

Event Narratives#

D

Patient 1

PATIENT SUSTAINED MINOR CUT ON HIS PENIS WHILE URINATING. EXAMINATION REVEALED THAT THE URINAL HAD AN EDGE WHICH WAS SHARP AND BURRED. UPON INVESTIGATION, AN ADDITIONAL FOUR URINALS WERE FOUND TO HAVE THE SAME PROBLEM. TREATED PATIENT'S CUT WITH TOPICAL BACITRACIN. HEALED SATISFACTORILY.WE HAVE CONTACTED THE DISTRIBUTOR WHO IS FILING A REPORT WITH THE MANUFACTURER.