MAUDE MDR 7723089

MDR report key
7723089
Report number
1417592-2018-00074
Event key
0
Event type
3
Date of event
2018-05-02
Date received
2018-07-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
NIGEL VILCHES
Address
THREE LAKES DRIVE NORTHFIELD IL 60093 US
Phone
224-224-2249
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1URINAL,MALE,SUPREMEMEDLINE INDUSTRIES INC.FNPDYND80235S308-1R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-07-2601. R

Event Narratives#

N

Patient 1

IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CUT TO HIS PENIS FROM A SHARP EDGE ON A URINAL. REPORTEDLY, THE PATIENT WAS BEING ASSISTED BY A NURSE WHILE IN AN EMERGENCY DEPARTMENT (ED). THE URINAL WAS BEING HELD BY THE NURSE. PER THE PATIENT'S FAMILY MEMBER, THE NURSE "MUST HAVE PUSHED REALLY HARD." THE REPORTED SHARP EDGE WAS LOCATED ON THE PIECE THAT CONNECTS THE LID TO THE URINAL. THE PATIENT WAS ADMITTED TO THE HOSPITAL FROM THE ED DUE TO THE UNIDENTIFIED COMPLAINT THAT INITIALLY BROUGHT HIM TO THE FACILITY. NO INFORMATION RELATED TO ED DIAGNOSTICS OR ED TREATMENTS WERE REPORTED TO THE MANUFACTURER. REPORTEDLY, THE PATIENT EXPERIENCED BRUISING, SWELLING, AND CONTINUED BLEEDING TO HIS PENIS AS HE TAKES AN UNIDENTIFIED "BLOOD THINNER." THE FAMILY MEMBER NOTED THAT A FOLEY CATHETER WAS INSERTED AS THE PATIENT EXPERIENCED DIFFICULTY TO "EMPTY HIS BLADDER." THIS FOLEY CATHETER WAS REMOVED WHEN THE PATIENT WAS DISCHARGED FROM THE FACILITY. ACCORDING TO THE FAMILY MEMBER, THE PATIENT HAS NO LONGER EXPERIENCED ISSUES WITH BLEEDING OR URINATION. NO SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. PHOTOS OF THE REPORTED SAMPLE WERE SUBMITTED TO THE MANUFACTURER. THE PHOTOS WERE REVIEWED AND THE MANUFACTURER IS UNABLE TO DETERMINE IF THERE ARE ANY SHARP EDGES. THE REPORTED PRODUCT ISSUE WAS NOT CONFIRMED AND ROOT CAUSE COULD NOT BE DETERMINED. DUE TO THE REPORTED INCIDENT AND THE NEED FOR MEDICAL INTERVENTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CUT TO HIS PENIS FROM A SHARP EDGE ON A URINAL. A FOLEY CATHETER WAS REPORTEDLY INSERTED.