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 |