MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-05-04 for THERASEED PALLADIUM 103 IMPLANTS MODEL 200 NA manufactured by Theragenics Corp.
[19174345]
Distributor mis-keyed the prescribed activity for this prostate brachytherapy order, specifying 1. 28 u sk,n99 (based on the nist 1999 wafac standard), when the user requested 1. 28 mci aapp,t97 (based on the cd-109 standard). Mfr filled the order as 1. 28 u sk,n99. Distributor and user received fax confirmations of the order prior to shipment, but did not detect the activity discrepancy. User's receiving procedures for the incoming order also did not reveal the activity discrepancy. The order was implanted in 2001 at an activity of 0. 74 mci aapp,t97 rather than the planned 1. 28 mci aapp,t97, resulting in a 41% misadministration (lower activity than prescribed). Theragenics was notified of the event by the user in 4/2001. The pt has not, and will not, experience permanent impairment or damage from this misadministration. The misadministration is being reported as a mdr adverse event, because the dose delivered was likely not high enough to be efficacious for the intended treatment of prostate cancer, and follow-up therapy will potentially be required to complete the pt's total treatment. Theragenics has referred the user for consultation to an oncologist experience in performing external beam boost treatments following prostate seed implants. The device order was implanted and, therefore, not returned for correction. No other pts or orders have been, nor will be, affected by this activity discrepancy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037598-2001-00001 |
| MDR Report Key | 330384 |
| Report Source | 05 |
| Date Received | 2001-05-04 |
| Date of Report | 2001-05-02 |
| Date of Event | 2001-02-26 |
| Date Mfgr Received | 2001-04-04 |
| Device Manufacturer Date | 2001-02-01 |
| Date Added to Maude | 2001-05-08 |
| 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 | 0 |
| Manufacturer Contact | LISA PEACOCK |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERASEED PALLADIUM 103 IMPLANTS |
| Generic Name | BRACHYTHERAPY IMPLANTS |
| Product Code | IWG |
| Date Received | 2001-05-04 |
| Model Number | MODEL 200 |
| Catalog Number | NA |
| Lot Number | 0107F |
| ID Number | ORDER NO. 139747 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 319744 |
| Manufacturer | THERAGENICS CORP |
| Manufacturer Address | 5203 BRISTOL INDUSTRIAL WAY BUFORD GA 30518 US |
| Baseline Brand Name | THERASEED |
| Baseline Generic Name | BRACHYTHERAPY SOURCE |
| Baseline Model No | MODEL 200 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | BRACHYTHERAPY SOURCE |
| 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 | 1. Other | 2001-05-04 |