MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-06-05 for THERASEED MODEL 200 TS200 manufactured by Theragenics Corp.
[126380]
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.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1057128-1999-00001 |
MDR Report Key | 229664 |
Report Source | 05 |
Date Received | 1999-06-05 |
Date of Report | 1999-06-04 |
Date of Event | 1999-04-13 |
Date Mfgr Received | 1999-05-07 |
Device Manufacturer Date | 1999-04-01 |
Date Added to Maude | 1999-07-02 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 0 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | THERASEED |
Generic Name | BRACHYTHERAPY IMPLANT |
Product Code | IWG |
Date Received | 1999-06-05 |
Model Number | MODEL 200 |
Catalog Number | TS200 |
Lot Number | 9914F & 9914G |
ID Number | * |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | UNKNOWN |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | U |
Device Sequence No | 1 |
Device Event Key | 222735 |
Manufacturer | THERAGENICS CORP |
Manufacturer Address | 5203 BRISTOL INDUSTRIAL WAY BUFORD GA 30518 US |
Baseline Brand Name | THERASEED |
Baseline Generic Name | RADIONUCLIDE BRACHYTHERAPY SOURCE |
Baseline Model No | MODEL 200 |
Baseline Catalog No | TS200 |
Baseline ID | NA |
Baseline Device Family | RADIONUCLIDE BRACHYTHERAPY SOURCE |
Baseline Shelf Life Contained | * |
Baseline Shelf Life [Months] | NA |
Baseline PMA Flag | N |
Baseline 510K PMN | Y |
Premarket Notification | K874787 |
Baseline Preamendment | N |
Baseline Transitional | N |
510k Exempt | N |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1999-06-05 |