MalfunctionIWG
THERASEED PALLADIUM 103 IMPLANTS
Received Sep 29, 2000 · Event occurred Sep 8, 2000
Report 1057128-2000-00001 · MDR key 298841
Device
Generic name
Brachytherapy Implants
Manufacturer
Theragenics Corp.Model number
MODEL 200 (DEVICE 1)Catalog number
NA
Lot number
0034F
Product problems
- Mislabeled
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
TWO SHIPMENTS WERE RECEIVED BY THE USER FACILITY, EACH HAVING A DIFFERENT LOT NUMBER. SHIPMENT A CONTAINED THE CERTIFICATION STATING PRODUCT IDENTITY FOR SHIPMENT B, AND SHIPMENT B CONTAINED THE CERTIFICATION FOR SHIPMENT A. THE ACTUAL DEVICE LABELS WERE CORRECT. THE USER FACILITY DETECTED THE ERROR, AND THERE WAS NO PT EFFECT. BOTH SHIPMENTS WERE RETURNED TO THE MFR.
Remedial action
- Replace