FDA Adverse Event
Malfunction
Summary report: N
THERASEED PALLADIUM 103 ISOTOPE
MDR report key: 219121
·
Received April 14, 1999
Report
- Report Number
- MW1016130
- Event Type
- Malfunction
- Date Received
- April 14, 1999
- Report Date
- April 13, 1999
- Manufacturer
- THERAGENICS CORP.
- Product Code
- IWG
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIST
Narratives
Description of Event or Problem · 1
TWO SHIPMENTS WERE RECEIVED, 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. IF THE PROBLEM HAD NOT BEEN NOTICED, PTS WOULD HAVE BEEN UNDERDOSED OR OVERDOSED BY 30% DEPENDING ON WHICH LOT NUMBER THEY RECEIVED. THE FACILITY USED THEIR OWN CALIBRATION SEED. THE PROBLEM WAS REPORTED TO THE MFR, BUT THE MFR JUST SAID THAT THE WRONG CALIBRATION SEED GOT IN THE WRONG SHIPMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THERASEED PALLADIUM 103 ISOTOPE | IMPLANT FOR PROSTATE CANCER | IWG | THERAGENICS CORP. | * | 9914F | |
| 2 | THERASEED PALLADIUM 103 ISOTOPE | IMPLANT FOR PROSTATE CANCER | IWG | THERAGENICS CORP. | * | 9914G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |