FDA.reportPublic FDA data

MAUDE MDR 6472523

MDR report key
6472523
Report number
1018233-2017-01637
Event key
0
Event type
3
Date of event
2017-03-02
Date received
2017-04-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
404
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 DELIVERY SYSTEM LOADERQUICKLINK LOADERBARD BRACHYTHERAPY, INC. -1424526IWJ70310QCA1NAY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-04-070

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 THE BIO-SPACERS SEEMED TO BE ESCAPING FROM THE DEVICE. THE COMPLAINANT REPORTED THAT WHEN THEY EJECTED THE SEEDS AND SENT THE TRAIN INTO THE NEEDLE, THE COUNT WOULD BE WRONG. WHEN THE TRAIN WAS PUSHED OUT OF THE NEEDLE, THERE WOULD BE NO BIO SPACER AT THE END. IN ADDITION, A SEED JAMMED IN THE GATE TWICE WHEN THE COMPLAINANT FORGOT TO "CRUNCH EVERYTHING TOGETHER." WHEN THE COMPLAINANT ATTEMPTED TO RETRIEVE THE SEEDS, SOME BIO SPACERS WERE FOUND UNDERNEATH. IT WAS NOTED THAT THE BUTTON OF THE GATE WAS NOT COMING UP FULLY.