FDA.reportPublic FDA data

MAUDE MDR 7104243

MDR report key
7104243
Report number
1018233-2017-06309
Event key
0
Event type
3
Date of event
2017-10-25
Date received
2017-12-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
300
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 BAGUNKNOWN LEG BAGC.R. BARD, INC. (COVINGTON) -1018233FAQUNKUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-12-110

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 TUBING OF THE LEG BAG SEPARATED FROM THE DIGNISHIELD. THE COMPLAINANT ALLEGED THAT THE LEG BAG CAUSED THE ISSUE