FDA.reportPublic FDA data

MAUDE MDR 3426618

MDR report key
3426618
Report number
1018233-2013-07824
Event key
0
Event type
3
Date of event
2013-09-09
Date received
2013-10-17
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
KIM SHIRAH
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
1BIOCATH COMPREHENSIVE CARE FOLEY TRAYBARD SDN. BHD.EZCNAD22655L16NGWK3225R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-10-1701. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE PT DEVELOPED A SKIN REACTION TO THE CATHETER, WHICH WAS PLACED SUPRAPUBICALLY. THE RASH WAS UNDER THE CATHETER, TRACKING ACROSS THE ABDOMEN AND DOWN THE LEG. WHEN THE CATHETER WAS REPOSITIONED, THE REACTION APPEARED AGAIN UNDER THE NEW POSITION. THE PT WAS TREATED WITH A BARRIER CREAM AND SWITCHED TO A SILICONE CATHETER, WHICH CAUSED NO REACTION.

N

Patient 1

THE SAMPLE WAS NOT RETURNED. THE INVESTIGATION REMAINS IN PROCESS. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.