FDA.reportPublic FDA data

MAUDE MDR 4847606

MDR report key
4847606
Report number
MW5043092
Event key
0
Event type
3
Date of event
2014-11-28
Date received
2015-06-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FREEDOM CATH FREEDOM COLOPLAST MALE EXTERNAL CATHETERMALE EXTERNAL CATHETER, 28MMCOLOPLAST A/SEXJ8200/8230 23301214002633

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-06-0901. H; 2. O

Event Narratives#

D

Patient 1

DUE TO BEING A QUADRIPLEGIC, I USE THE FREEDOM CATH. ON (B)(4) 2014 WHEN I GOT UP TO REMOVE THE CATHETER, IT PULLED THE SKIN OFF MY PENIS. I HAVE UNDERGONE SEVERAL SURGERIES ALREADY, AND MY DOCTOR IS NOW TALKING ABOUT REMOVING A PORTION OF MY PENIS. I HAVE ALREADY UNDERGONE TWO SURGERIES AND WILL NEED A THIRD.