THERASEED PALLADIUM 103 ISOTOPE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-04-14 for THERASEED PALLADIUM 103 ISOTOPE * manufactured by Theragenics Corp..

Event Text Entries

[127766] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1016130
• MDR Report Key: 219121
• Date Received: 1999-04-14
• Date of Report: 1999-04-13
• Date Added to Maude: 1999-04-19
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PHYSICIST
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: THERASEED PALLADIUM 103 ISOTOPE
• Generic Name: IMPLANT FOR PROSTATE CANCER
• Product Code: IWG
• Date Received: 1999-04-14
• Model Number: *
• Catalog Number: *
• Lot Number: 9914F
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 212505
• Manufacturer: THERAGENICS CORP.
• Manufacturer Address: 5325 OAKBROOK PARKWAY NORCROSS GA 30093 US

Device Sequence Number: 2

• Brand Name: THERASEED PALLADIUM 103 ISOTOPE
• Generic Name: IMPLANT FOR PROSTATE CANCER
• Product Code: IWG
• Date Received: 1999-04-14
• Model Number: *
• Catalog Number: *
• Lot Number: 9914G
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 212581
• Manufacturer: THERAGENICS CORP.
• Manufacturer Address: 5325 OAKBROOK PKWY NORCROSS GA 30093 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1999-04-14