MalfunctionIWG
THERASEED
Received Jun 5, 1999 · Event occurred Apr 13, 1999
Report 1057128-1999-00001 · MDR key 229664
Device
Generic name
Brachytherapy Implant
Manufacturer
Theragenics CorpModel number
MODEL 200Catalog number
TS200
Lot number
9914F & 9914G
Product problems
- Off-Label Use
- Out-Of-Box Failure
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
TWO SHIPMENTS WERE REC'D BY THE USER FACILITY, EACH HAVING A DIFFERENT LOT NUMBER. SHIPMENT A CONTAINED THE CALIBRATION SEED FOR SHIPMENT B AND SHIPMENT B CONTAINED THE CALIBRATION SEED FOR SHIPMENT A. THE USER FACILITY DETECTED THE ERROR AND THERE WAS NO PT IMPACT.