D
Patient 1
THIS MOUTH GAG BROKE DURING A TONSILLECTOMY PROCEDURE. THE PHYSICIAN PRESENT DURING THE PROCEDURE EXAMINED THE PT AND INDICATED THAT THERE WERE NO PT PROBLEMS AS A RESULT OF THIS EVENT.
MAUDE MDR 77256
- MDR report key
- 77256
- Report number
- 1932180-1997-00032
- Event key
- 0
- Event type
- 3
- Date of event
- 1997-02-11
- Date received
- 1997-03-17
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | STORZ LEIVERS MOUTH GAG FRAME, CHILD SIZE | MOUTH GAG | STORZ INSTRUMENT CO. | KBN | NA | N7537 L | NA | N | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 1997-03-17 | 0 |