FDA.reportPublic FDA data

MAUDE MDR 9853187

MDR report key
9853187
Report number
1018233-2020-01914
Event key
0
Event type
3
Date received
2020-03-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
YONIC ANDERSON
Address
8195 INDUSTRIAL BLVD COVINGTON GA 30014 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PERSONAL CATHETER? INTERMITTENT CATHETERMAGIC 3 CATHETERC.R. BARD, INC. (COVINGTON) -1018233KOD6260862608UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-190

Event Narratives#

N

Patient 1

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAKAGE WITH THE CATHETER. PER ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT VIA EMAIL ON 26FEB2020, FLUID LEAKED OUT WHEN THE PACKAGING WAS OPENED AND "NOT STAYING TOGETHER. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER CONTACT VIA PHONE ON 26FEB2020, IT WAS NOTED THAT THERE WAS NO LEAKAGE WITH THE DEVICE, HOWEVER, THE CATHETER REPORTEDLY WOULD LOOSE LUBRICATION IN THE MIDDLE OF CATHING AND SOMETIMES IT WAS NOT LUBRICATED ENOUGH TO INSERT SO THE PATIENT EXPERIENCED PAIN WITH INSERTION. NO MEDICAL INTERVENTION WAS REPORTED.