FDA Adverse Event
Other
Summary report: N
IMPACT AIR FIBER OPTIC H.P.
MDR report key: 110918
·
Received August 6, 1997
Report
- Report Number
- 2511504-1997-00001
- Event Type
- Other
- Date Received
- August 6, 1997
- Date of Event
- May 16, 1997
- Report Date
- August 5, 1997
- Manufacturer
- GLENWOOD-PALISADES
- Product Code
- DZA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
NOTIFIED BY THE DISTRIBUTOR THAT THE HEAD CAP AND TURBINE CAME OFF IN THE PATIENT'S MOUTH AND WAS REPORTED SWALLOWED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPACT AIR FIBER OPTIC H.P. | HANDPIECE DENTAL DRILL | DZA | GLENWOOD-PALISADES | 45 SL | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |