FDA.reportPublic FDA data

MAUDE MDR 3995237

MDR report key
3995237
Report number
1480288-2014-00003
Event key
0
Event type
3
Date of event
2014-07-09
Date received
2014-08-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
ANNE RIBA
Address
2000 HOLLISTER DR LIBERTYVILLE IL 60048 US
Phone
847-847-8476
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1INVIEW MALE EXTERNAL CATHETERSILICONE EXTERNAL CATHETERHOLLISTER INCORPORATEDEXJ97636R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-08-0801. H; 2. O

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT AN EXTERNAL CATHETER, HOLLISTER (B)(4) WAS APPLIED TO A (B)(6) USER ON (B)(6) AT MIDNIGHT. THE NEXT MORNING ((B)(4) 2014) AT 7AM THE EXTERNAL CATHETER WAS REMOVED WITH WARM WATER AND VASELINE. FOLLOWING REMOVAL, 2 TEARS WERE OBSERVED ON THE PENIS WHICH APPEARED TO BE STRAIGHT 'RAZOR BLADE-LIKE' TEARS; NO BLEEDING WAS NOTED. THE LOWER TEAR WAS APPROXIMATELY 1" AND THE UPPER TEAR WAS APPROXIMATELY 1/2". THE TEARS WERE TREATED USING OTC ANTIBIOTIC CREAM AND BODY WASH. THE USER WENT TO HIS REGULARLY SCHEDULED DOCTOR APPOINTMENT ON (B)(4) WHERE THE DOCTOR INSTRUCTED THEM TO CONTINUE WITH THE OTC ANTIBIOTIC. THE USER ALSO TOOK HIS DILAUDID PAIN MEDICINE (PREVIOUSLY PRESCRIBED FOR THE TREATMENT NEUROFIBROMATOSIS) TO EASE THE PAIN. AS OF (B)(6) 2014 THE USER'S PENIS WAS COMPLETELY HEALED.

N

Patient 1

IT WAS REPORTED THAT THE CAREGIVER HAD REQUESTED A SHEATH FOR HER SON THAT WAS LONGER THAN THE NORMAL ONE SHE USED (HOLLISTER (B)(4)). THE MEDICAL SUPPLIER INSTEAD PROVIDED HER WITH A PRODUCT WITH EXTRA ADHESIVE (HOLLISTER (B)(4)). THE CAREGIVER HAS BEEN GIVEN THE CORRECT SKU FOR A LONGER SHEATH PRODUCT WITH NO EXTRA ADHESIVE.