MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-09-29 for THERASEED PALLADIUM 103 IMPLANTS MODEL 200 (DEVICE 1) NA manufactured by Theragenics Corp..
[200546]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057128-2000-00001 |
| MDR Report Key | 298841 |
| Report Source | 05,06 |
| Date Received | 2000-09-29 |
| Date of Report | 2000-09-28 |
| Date of Event | 2000-09-08 |
| Date Mfgr Received | 2000-09-08 |
| Device Manufacturer Date | 2000-09-01 |
| Date Added to Maude | 2000-10-05 |
| 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 |
| Reporter Occupation | PHYSICIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JANET ZEMAN |
| Manufacturer Street | 5203 BRISTOL INDUSTRIAL WAY |
| Manufacturer City | BUFORD GA 30518 |
| Manufacturer Country | US |
| Manufacturer Postal | 30518 |
| Manufacturer Phone | 7702710233 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERASEED PALLADIUM 103 IMPLANTS |
| Generic Name | BRACHYTHERAPY IMPLANTS |
| Product Code | IWG |
| Date Received | 2000-09-29 |
| Returned To Mfg | 2000-09-08 |
| Model Number | MODEL 200 (DEVICE 1) |
| Catalog Number | NA |
| Lot Number | 0034F |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 289273 |
| Manufacturer | THERAGENICS CORP. |
| Manufacturer Address | 5203 BRISTOL INDUSTRIAL WAY BUFORD GA 30518 US |
| Baseline Brand Name | THERASEED PALADIUM 103 IMPLANTS |
| Baseline Generic Name | BRACHYTHERAPY IMPLANTS |
| Baseline Model No | MODEL 200 (DEVI |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-09-29 |