FDA.reportPublic FDA data

MAUDE MDR 5753947

MDR report key
5753947
Report number
1018233-2016-00806
Event key
0
Event type
3
Date received
2016-06-27
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
1BARDEX I.C. 5CC LATEX FOLEY CATHETER WITH SILVER/HYDROGEL COATINGFOLEY CATHETERBARD SDN. BHD. -8040607MJC0165SI16UNKY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-06-2701. R

Event Narratives#

N

Patient 1

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. 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 PRODUCT DEVELOPED CALCIFICATION AROUND THE TIP AND THIS CAUSED PAIN AND TRAUMA TO THE URETHRA UPON REMOVAL. THE CATHETER WAS PLACED ON ((B)(6) 2016) AND TAKEN OUT ((B)(6) 2016).

N

Patient 1

THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE PHOTO ATTACHED, THE REPORTED EVENT WAS CONFIRMED. ENCRUSTATION WAS OBSERVED ON THE EXTERIOR OF THE BALLOON AND TIP END OF THE SAMPLE. THE REPORTED EVENT WAS CONFIRMED AS USE-RELATED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE CAUTION STATE "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." (B)(4). 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. PHOTO SAMPLE WAS RECEIVED.