FDA Adverse Event
Injury
Summary report: N
DENTO-SURG 90 FFP
MDR report key: 285906
·
Received July 17, 2000
Report
- Report Number
- 2428235-2000-00004
- Event Type
- Injury
- Date Received
- July 17, 2000
- Date of Event
- November 16, 1998
- Report Date
- July 17, 2000
- Manufacturer
- ELLMAN INTERNATIONAL INC.
- Product Code
- EKZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
BONE DEATH WITH NECROSIS OF EPITHELIAL ATTACHMENT RE: TOOTH #11.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DENTO-SURG 90 FFP | RADIOSURGERY GENERATOR | EKZ | ELLMAN INTERNATIONAL INC. | 90 FFP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |