FDA.reportPublic FDA data

MAUDE MDR 6817875

MDR report key
6817875
Report number
1018233-2017-04421
Event key
0
Event type
3
Date received
2017-08-24
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
1QUICKLINK? LOADERQUICKLINK LOADERBARD BRACHYTHERAPY, INC. -1424526IWJ70310QCA1NAY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-240

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 THERE WAS A CRACK IN THE DEVICE. WHEN THE HOSPITAL WANTED TO USE THIS QUICKLINK FOR A PROCEDURE, THEY WERE NOT ABLE TO TURN/FIXATE THE SCREW BECAUSE THE SCREW "WIRE" WAS TORN/DAMAGED. THEREFORE, THE PROCEDURE WAS CANCELLED BY THE HOSPITAL AND THE PATIENT WAS NOT TREATED.