D
Patient 1
IT WAS REPORTED TO BSC/TARGET THAT DURING THE PROCEDURE THE DSB DETACHABLE SILICONE BALLOON DETACHED PREMATURELY. THE CONDITION OF THE PATIENT IS UNKNOWN. COMPANY REPRESENTATIVE WILL FOLLOW-UP WITH ADDITIONAL INFORMATION.
MAUDE MDR 384130
- MDR report key
- 384130
- Report number
- 6000078-2002-00019
- Event key
- 0
- Event type
- 3
- Date of event
- 2002-02-13
- Date received
- 2002-03-19
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- ANITA NEUMAN
- Address
- 47900 BAYSIDE PARKWAY FREMONT CA 94538 US
- Phone
- 800-800-8006
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DSB DETACHABLE SILICONE BALLOON | DETACHABLE BALLOON | TARGET THERAPEUTICS/A DIVISION OF BOSTON SCIENTIFIC CORPORATION | MZQ | * | TBD | TBD | Y | R | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2002-03-19 | 0 |