D
Patient 1
THE CUSTOMER REPORTS THAT THE BALLOON BUSTED.
MAUDE MDR 372940
- MDR report key
- 372940
- Report number
- 8040412-2002-00012
- Event key
- 0
- Event type
- 3
- Date received
- 2002-01-17
- 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
- DONNA MCLEOD
- Address
- 2450 MEADOWBROOK PARKWAY DULUTH GA 30096 US
- Phone
- 770-770-7706
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | RUSCH | ST. BARTHOLOMEW CATHETER | RUSCH SDN. BHD. | GBT | NA | 264030 | 97NSI1 | K841036 | N | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2002-01-17 | 0 |