D
Patient 1
COMPLAINANT REPORTED THAT BLOOD ENTERED THE CATHETER DURING VASCULAR BRACHY THERAPY PROCEDURE.
MAUDE MDR 388507
- MDR report key
- 388507
- Report number
- 1062385-2002-00013
- Event key
- 0
- Event type
- 3
- Date received
- 2002-12-12
- 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 | 40MM BETA-CATH DELIVERY CATHETER | CATHETER | NOVOSTE CORPORATION | MOU | 510609-040 | BCK-0140 | UNK | N | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2002-12-12 | 0 |