FDA.reportPublic FDA data

MAUDE MDR 5011897

MDR report key
5011897
Report number
3005945907-2015-00001
Event key
0
Event type
3
Date of event
2014-11-28
Date received
2015-08-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. BRIANNA MACDONALD
Address
1601 W RIVER RD N 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 MEDIUMDEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILECOLOPLAST A/SEXJ506130140050613014004002633R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-08-1801. R

Event Narratives#

N

Patient 1

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 ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

D

Patient 1

ACCORDING TO THE INFORMATION RECEIVED, VIA MEDWATCH MW5043092, IN 2014, WHEN CUSTOMER GOT UP TO REMOVE THE CATHETER, IT PULLED THE SKIN OFF HIS PENIS. HE HAS UNDERGONE SEVERAL SURGERIES ALREADY, AND DOCTOR IS NOW TALKING ABOUT REMOVING A PORTION OF THE PENIS. CUSTOMER HAS ALREADY UNDERGONE TWO SURGERIES AND WILL NEED A THIRD. CUSTOMER STATED THAT HE HAD BEEN USING MEC'S FOR ABOUT 14 YEARS PRIOR TO THIS INCIDENT. HE MAINLY USED THEM AT NIGHT. HE MENTIONED ONE MORNING BACK IN (B)(6) 2014 HE WENT TO UNROLL THE MEC FROM HIS PENIS AND ALL THE "SKIN AND MEAT" WAS REMOVED WITH THE MEC. THE DOCTORS HAVE TRIED TO REPLACE THE SKIN FROM OTHER PARTS OF HIS BODY BUT IT HASN'T BEEN VERY SUCCESSFUL. HE DOESN'T USE MEC'S RIGHT NOW. WHEN ASKED IF IT WAS A COLOPLAST MEC THAT WAS THE DIRECT CAUSE, HE SAID YES.