D
Patient 1
THE BALLOON DID NOT INFLATE.
MAUDE MDR 276054
- MDR report key
- 276054
- Report number
- MW1018786
- Event key
- 0
- Event type
- 3
- Date of event
- 2000-04-27
- Date received
- 2000-04-28
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 500
- Health professional
- 3
- Initial report to FDA
- 0
- Event location
- 3
Manufacturer Contact#
- Report source
- P
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AUTOSUTURE | INFLATION BULB | UNITED STATES SURGICAL CORP. | FHO | OMST10SB | * | 203219 | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2000-04-28 | 0 | 1. O |