FDA.reportPublic FDA data

MAUDE MDR 5067833

MDR report key
5067833
Report number
1018233-2015-00342
Event key
0
Event type
3
Date of event
2015-06-04
Date received
2015-09-10
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
CHRISTY LEWIS
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
12-WAY 5CC LATEX FOLEY CATHETERFOLEY CATHETERBARD SDN. BHD. -8040607EZC0165L16UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-09-1001. R

Event Narratives#

N

Patient 1

THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN, THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "SINGLE PATIENT USE ONLY. DO NOT REUSE. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE." THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED A URINARY TRACT INFECTION ON (B)(6) 2015 AS A RESULT OF USING THE CATHETER. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2015 FOR ACUTE METABOLIC ENCEPHALOPATHY SECONDARY TO UNDERLYING URINARY RETENTION AND A URINARY TRACT INFECTION. A FOLEY CATHETER WAS PLACED AND 800MLS OF URINE WAS RETURNED. FOLLOW UP URINE CULTURES WERE NEGATIVE.