MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-07-12 for THERASEED PD-103 IMPLANTS MODEL 200 NA manufactured by Theragenics Corp..
[243906]
An associate of the hospital's health physicist placed a prostate brachytherapy order for 1. 4 mci, and the order was entered using manufacturer's standard procedures as 1. 4 mci aapp,t97 (based on the cd-109 standard). The hospital's health physicist intended a prescription of 1. 8 u sk, n99 (based on the nist 1999 wafac standard), which corresponded to 1. 1 mci aapp,t97 rather than 1. 4 mci aapp, t97. User received a fax confirmation 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 1. 36 mci aapp, t97, equivalent to 2. 19 u sk, n99, rather than the planned 1. 8 u sk, n99, resulting in a 21% misadministration (higher activity than prescribed). Theragenics was notified of the event by the user the next day. The patient has not experienced impairment or damage from this misadministration. The health physicist has stated that he does not anticipate future complications. A six-week check-up is scheduled for patient evaluation, and the manufacturer will re-contact the hospital to determine patient's status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037598-2001-00002 |
| MDR Report Key | 342249 |
| Report Source | 05 |
| Date Received | 2001-07-12 |
| Date of Report | 2001-07-12 |
| Date of Event | 2001-06-19 |
| Date Mfgr Received | 2001-06-20 |
| Device Manufacturer Date | 2001-06-01 |
| Date Added to Maude | 2001-07-19 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERASEED PD-103 IMPLANTS |
| Generic Name | BRACHYTHERAPY IMPLANTS |
| Product Code | IWG |
| Date Received | 2001-07-12 |
| Model Number | MODEL 200 |
| Catalog Number | NA |
| Lot Number | 0123H |
| ID Number | ORDER NO. 084863 |
| 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 | 331584 |
| 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 | 2001-07-12 |