FDA.reportPublic FDA data

MAUDE MDR 5811154

MDR report key
5811154
Report number
1018233-2016-00930
Event key
0
Event type
3
Date received
2016-07-20
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
JANNA PARKS
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
1LATEX FOLEY CATHETERCATHETERBARD SDN. BHD. -8040607EZCUNKUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-07-2001. R

Event Narratives#

N

Patient 1

THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER AND PRODUCT NUMBER IS UNKNOWN THEREFORE THE DEVICE HISTORY RECORD AND LABELING COULD NOT BE REVIEWED. ALTHOUGH THE PRODUCT FAMILY IS UNKNOWN, THE LATEX PRODUCT IFUS ARE FOUND TO BE ADEQUATE BASE ON PAST REVIEWS. THE DEVICE WAS DISCARDED.

D

Patient 1

IT WAS REPORTED THAT EITHER THE CATHETER WAS CLOGGED, OR THE HOLE WAS TO NARROW TO DRAIN THE URINE. AS A RESULT, THE CATHETER WAS IRRIGATED WHICH ALLOWED THE URINE TO DRAIN. A BLADDER SCAN WAS PERFORMED AND IT WAS DISCOVERED THAT THE PATIENT ALLEGEDLY EXPERIENCED URINE RETENTION.

N

Patient 1

THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER AND PRODUCT NUMBER IS UNKNOWN THEREFORE THE DEVICE HISTORY RECORD AND LABELING COULD NOT BE REVIEWED. ALTHOUGH THE PRODUCT FAMILY IS UNKNOWN, THE LATEX PRODUCT IFUS ARE FOUND TO BE ADEQUATE BASE ON PAST REVIEWS. (B)(4). THE DEVICE WAS DISCARDED.

D

Patient 1

IT WAS REPORTED THAT EITHER THE CATHETER WAS CLOGGED, OR THE HOLE WAS TOO NARROW TO DRAIN THE URINE. AS A RESULT, THE CATHETER WAS IRRIGATED WHICH ALLOWED THE URINE TO DRAIN. A BLADDER SCAN WAS PERFORMED AND IT WAS DISCOVERED THAT THE PATIENT ALLEGEDLY EXPERIENCED URINE RETENTION.