FDA.reportPublic FDA data

MAUDE MDR 6391210

MDR report key
6391210
Report number
1018233-2017-00966
Event key
0
Event type
3
Date received
2017-03-09
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
AMY GRAVLEY
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
1BARD DISPOZ-A-BAG LEG BAGDRIAN BAGPRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590FAQUNKUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-03-090

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 STATE THE FOLLOWING: "VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. IF PACKAGE IS OPENED OR IF ANY IMPERFECTION OR SURFACE DETERIORATION IS OBSERVED, DO NOT USE; PERIODIC OBSERVATIONS OF THIS SYSTEM SHOULD BE MADE TO ENSURE THAT URINE IS FLOWING FREELY. IF A STANDING COLUMN OF URINE IS OBSERVED, CHECK FOR CORRECT POSITIONING OF BAG AND THEN FOR A PHYSICAL OBSTRUCTION. IF CORRECT POSITIONING OR REMOVAL OF PHYSICAL OBSTRUCTION DOES NOT ALLOW FREE FLOW, THE BAG MAY HAVE TO BE CHANGED; KINK DRAINAGE TUBING A MINIMUM OF 3 INCHES BELOW THE SAMPLING PORT UNTIL URINE IS VISIBLE UNDER THE ACCESS SITE." (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.

D

Patient 1

IT WAS REPORTED THAT THE DRAIN BAG WOULD NOT DRAIN URINE UNLESS THE BED WAS RAISED, AND THE DRAIN BAG PLACED ON THE FLOOR.