FDA.reportPublic FDA data

MAUDE MDR 7485823

MDR report key
7485823
Report number
1018233-2018-01482
Event key
0
Event type
3
Date of event
2018-04-09
Date received
2018-05-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
YONIC ANDERSON
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? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGESSEEDSBARD BRACHYTHERAPY, INC. -1424526KXK1251CSR1251CSRUNKY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-05-030

Event Narratives#

N

Patient 1

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. BM (B)(4) IS ASSOCIATED WITH THIS EVENT. 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 FACILITY RECEIVED SEEDS WITH PRODUCT CODE (B)(4) (SALES ORDER (B)(4)) THAT WERE INTENDED FOR A DIFFERENT FACILITY, INSTEAD OF THE SEEDS THAT WERE ORDERED (1251CSR AND 1251CSRA - SALES ORDER (B)(4)). THE INITIAL INVESTIGATION INTO THE ISSUE INDICATES THAT THE FEDEX LABELS ON THE OUTER SHIPPING BOXES WERE SWITCHED. THE SEEDS THAT THE FACILITY RECEIVED ((B)(4)) WERE REPORTEDLY USED ON THE PATIENT AND THE PATIENT RECEIVED THE CORRECT DOSAGE WITHOUT IMPACT.