FDA.reportPublic FDA data

MAUDE MDR 3162092

MDR report key
3162092
Report number
2130787-2013-00001
Event key
0
Event type
3
Date of event
2013-05-15
Date received
2013-05-30
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
1IN VIEW STANDARD MALE EXTERNAL CATHETERMALE EXTERNAL CATHETERROCHESTER MEDICAL CORP.EXJ97536UNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-05-3001. O

Event Narratives#

D

Patient 1

ON (B)(4) 2013, ROCHESTER MEDICAL CORPORATION WAS NOTIFIED THAT AN END USER OF A MALE EXTERNAL CATHETER HAD DIFFICULTY IN REMOVING THE CATHETER. THE END USER REPORTED THAT THE ADHESIVE APPEARED TO BE TOO STRONG AND INJURED HIS PENIS. THE END USER REPORTED THAT HE CONSULTED A DERMATOLOGIST WHO PRESCRIBED MUPIROCIN OINTMENT AS TREATMENT.