FDA.reportPublic FDA data

MAUDE MDR 5682475

MDR report key
5682475
Report number
1018233-2016-00699
Event key
0
Event type
3
Date of event
2016-05-06
Date received
2016-05-26
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
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
1BENELUX BIOCATHETERFOLEY BIOCATHBARD SDN. BHD. -8040607EZC226516MYVHR523R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-05-260

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 THE FOLEY CATHETER WAS INSERTED THROUGH SUPRA PUBIC PLACEMENT AND THE BALLOON WOULDN'T INFLATE AND RESISTANCE OCCURRED. THERE WAS NO REPORTED PATIENT INJURY.

N

Patient 1

THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "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. SAMPLE NOT AVAILABLE.