FDA.reportPublic FDA data

MAUDE MDR 6024632

MDR report key
6024632
Report number
3006606901-2016-00036
Event key
0
Event type
3
Date received
2016-10-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Contact
CHRISTINE BUCKVOLD
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
1CONVEEN OPTIMA ?35MALE EXTERNAL CATHETER-UROSHEATHCOLOPLAST A/SEXJ220350100122035010015250912N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-10-1201. O

Event Narratives#

N

Patient 1

NO ADDITIONAL COMPLAINTS REGISTERED ABOUT THIS LOT NUMBER. NO ADDITIONAL COMPLAINTS REGISTERED ABOUT THIS ITEM NO. CURRENT MONTH SAME ISSUE. COMPLAINTS SUCH AS THIS IS A NEW ISSUE WITH THIS PRODUCT LINE. THE COMPLAINTS ARE MONITORED CLOSELY FOR A FORMING TREND AND REPORTED TO MANAGEMENT ON A MONTHLY BASIS. A RECHECK OF THE PRODUCT DOCUMENTATION FOR THIS LOT NUMBER DID NOT REVEAL ANY NORM DEVIATION THAT COULD BE RELATED TO THE COMPLAINT.

D

Patient 1

ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT WAS NOT A FIRST TIME USER AND HAD USED THE URISHEATH FOR ABOUT 45 DAYS WITH CONVEEN ACTIVE. HE CHANGED THE PRODUCT EVERY DAY AND CLEANED HIS SKIN WITH WATER AND SOAP. SKIN IRRITATION WAS OBSERVED AFTER 30 DAYS OF USE. THERE WAS REDNESS, SKIN BLISTER ON EACH SIDE OF THE PENIS WHERE VEINS WERE VISIBLE AND A LITTLE UNDER. THERE WAS PAIN (ITCHING AND BURNING SENSATION) AT THE BASE OF THE PENIS WHERE THE URISHEATH STOPPED. THE PATIENT SAW A DOCTOR WHO PRESCRIBED A CREAM (POMADE) NAMED BIAFINE 3 TIMES A DAY. THE SKIN IRRITATION WAS A LITTLE BETTER AND THE PATIENT SWITCHED TO ANOTHER BRAND.