FDA.reportPublic FDA data

MAUDE MDR 6616372

MDR report key
6616372
Report number
1018233-2017-02978
Event key
0
Event type
3
Date received
2017-06-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
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 BAGLEG BAGPRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590FAQUNKUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-06-060

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. THE DEVICE WAS NOT RETURNED.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT WAS ALLEGEDLY HAVING ISSUES GETTING URINE TO DRAIN INTO THE LEG BAG. HE WAS ADVISED, BY MS&S, THAT THE ISSUE COULD BE DUE TO THE AIR LOCK. HE DESCRIBED HOW THE BAG WAS NOT VENTED LIKE THE OVERNIGHT BAG. THE FRONT AND BACK OF THE BAG HAD TO BE PULLED APART TO GET AIR INTO THE TUBING. HE WAS ADVISED THAT WHEN USING A MALE EXTERNAL CATHETER, THE TUBING SHOULD BE KEPT STRAIGHT TO KEEP THE URINE FROM BACKING UP INTO THE TUBING.