D
Patient 1
THE RADIOACTIVE SOURCES WERE LEFT IN THE PT AT THE TREATMENT SITE FOR A 30 SECOND DELAY AFTER THE INTENDED TREATMENT TIME. PT IS IN STABLE CONDITION. THE SITE INDICATED THAT THEY WERE REPORTING THE RADIATION EVENT TO THE STATE.
MAUDE MDR 465393
- MDR report key
- 465393
- Report number
- 1062385-2003-00009
- Event key
- 0
- Event type
- 3
- Date of event
- 2003-05-19
- Date received
- 2003-06-06
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- ADAM LOWE, VP
- Address
- 3890 STEVE REYNOLDS BLVD NORCROSS GA 30093 US
- Phone
- 770-770-7707
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 3.5F BETA-RAIL DELIVERY CATHETER | CATHETER | NOVOSTE CORP. | MOU | P00563 | ABR-0340 | 614298 | P0000 | N | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2003-06-06 | 0 | 1. O |