FDA.reportPublic FDA data

MAUDE MDR 9612997

MDR report key
9612997
Report number
9616668-2020-00001
Event key
0
Event type
3
Date of event
2019-12-24
Date received
2020-01-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. LINDA WISOWATY
Address
2000 HOLLISTER DRIVE LIBERTYVILLE IL 60048 US
Phone
847-847-8476
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VAPRO STANDARD CH 14 40 CM INTERMITTENT CATHETERVAPRO STANDARD CH 14 40 CM INTERMITTENT CATHETERHOLLISTER INCORPORATEDGBM72144UNKNOWNN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-2101. R

Event Narratives#

N

Patient 1

DHR REVIEW NOT POSSIBLE BECAUSE LOT NUMBER IS NOT KNOWN. SAMPLE EVALUATION NOT POSSIBLE BECAUSE DEVICE NOT RETURNED TO HOLLISTER FOR TESTING. TREND ANALYSIS CONDUCTED AND THIS IS APPEARS TO BE AN ISOLATED EVENT. PATIENT'S AGE AND WEIGHT ARE NOT KNOWN SO ESTIMATIONS USED. CAUSE OF BLISTERS NOT DETERMINED. REASON FOR ANTIBIOTIC USE NOT PROVIDED.

D

Patient 1

THE END USER REPORTED THAT HE FELT STINGING WHEN INSERTING THE VAPRO INTERMITTENT URINARY CATHETERS. HE STATED THEY WERE GIVING HIM BLISTERS. HE SAID THAT HIS DOCTOR SAID THAT HE HAD BLISTERS IN HIS URETHRA POSSIBLY FROM THE CATHETERS. HE IS ON ANTIBIOTICS BUT HE DID NOT STATE WHY HE WAS ON ANTIBIOTICS.