FDA.reportPublic FDA data

MAUDE MDR 3299438

MDR report key
3299438
Report number
2130787-2013-00002
Event key
0
Event type
3
Date received
2013-08-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
ROB ANGLIN
Address
ONE ROCHESTER MEDICAL DR. STEWARTVILLE MN 55976 US
Phone
507-507-5075
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SPIRIT MALE EXTERNAL CATHETERMALE EXTERNAL CATHETERROCHESTER MEDICAL CORP.EXJ39301UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-08-1401. O

Event Narratives#

D

Patient 1

ON (B)(6) 2013, ROCHESTER MEDICAL CORPORATION WAS CONTACTED BY AN END USER OF A SELF ADHERING MALE EXTERNAL CATHETER WHO STATED THAT HE DEVELOPED A SORE ON HIS PENIS. THE END USER STATED THAT HE CONSULTED HIS PHYSICIAN ABOUT THE SORE. THE PHYSICIAN PRESCRIBED A DUODERM HYDROCOLLOID PATCH TO COVER THE SORE. THE END USER STATES THAT HE THEN CAN CONTINUE USE OF THE MALE EXTERNAL CATHETER OVER THE PATCH. THE END USER STATES THAT THE SORE CLEARS UP WITH USE OF THE HYDROCOLLOID PATCH. THE END USER CONTINUED USE OF THE MALE EXTERNAL CATHETER WITHOUT THE HYDROCOLLOID PATCH AND THE SORE RETURNS. THE END USER ALSO STATED THAT HE USES A SKIN PREP ADHESIVE WITH THE MALE EXTERNAL CATHETER AS WELL AS EXTERNAL TAPE TO KEEP THE CATHETER IN PLACE. THE END USER STATED THAT HE HAS DONE THIS WITH ALL OF HIS MALE EXTERNAL CATHETERS OVER THE LAST 10+ YEARS.