FDA.reportPublic FDA data

MAUDE MDR 2853317

MDR report key
2853317
Report number
3005945907-2012-00011
Event key
0
Event type
3
Date of event
2012-03-28
Date received
2012-07-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Contact
MR BRIAN
Address
1601 WEST RIVER ROAD NORTH MINNEAPOLIS MN 55411 US
Phone
612-612-6123
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FREEDOM CATH MEDIUMMALE EXTERNAL CATHETERCOLOPLAST A/SEXJ506130140050613014002990000R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-07-0201. O

Event Narratives#

D

Patient 1

ACCORDING TO THE INFO RECEIVED A USER IS HAVING ISSUES WITH THE EXTERNAL CONDOM CATHETER IRRITATING HIS FORESKIN. THE DEVICE IS TAKING HIS SKIN OFF. THE USER STATED HE WAS NOT SURE IF IT WAS AN ADHESION PROBLEM OR URINE POOLING NEAR THE FORESKIN. HE STATED THIS PROBLEM HAD BEEN ONGOING FOR SEVERAL YEARS AND HE WILL BE SEEING A DOCTOR REGARDING THIS ISSUE.

N

Patient 1

THE PRODUCT WAS NOT AVAILABLE TO BE RETURNED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD THE DEVICE OR ADD'L INFO BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.