FDA.reportPublic FDA data

MAUDE MDR 133621

MDR report key
133621
Report number
9610077-1997-00013
Event key
0
Event type
3
Date of event
1997-10-19
Date received
1997-11-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
405
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THERATRONCOBALT TELETHERAPY DEVICETHERATRONICS INTL., LTD.IWDT1000G90NANNY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11997-11-1501. O

Event Narratives#

D

Patient 1

A SERVICE REP REPORTED THAT THE RADIOACTIVE SOURCE FAILED TO RETRACT TO THE FULLY SHIELDED POSITION. THE EVENT OCCURRED FOLLOWING INSTALLATION OF A REPLACEMENT FIELD LIGHT ASSEMBLY AND WHILE THE UNIT WAS UNDERGOING TESTS PRIOR TO RE-RELEASING THE UNIT FOR CLINICAL USE.