D
Patient 1
DIFFICULTY RETURNING SOURCES TO THE TRANSFER DEVICE. SOURCE CONTAMINATED IN CLOSED SYSTEM WAS COMPROMISED. ALL RADIOACTIVE MATERIALS WERE POSITIVELY IDENTIFIED AND ACCOUNTED FOR.
MAUDE MDR 423547
- MDR report key
- 423547
- Report number
- 1062385-2002-00015
- Event key
- 0
- Event type
- 3
- Date of event
- 2001-10-08
- Date received
- 2002-10-17
- 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 RA
- 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 | ALPHA IV REV.3 40MM ACTIVE TRANSFER DEVICE | TRANSFER DEVICE | NOVOSTE CORP. | MOU | A1733 | WLC-0001-042 | NA | P0000 | N | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2002-10-17 | 0 |