FDA Adverse Event
Injury
Summary report: N
DENOPTIX DIGITAL IMAGING SYSTEM
MDR report key: 494845
·
Received November 12, 2003
Report
- Report Number
- 1419870-2003-00197
- Event Type
- Injury
- Date Received
- November 12, 2003
- Report Date
- October 14, 2003
- Manufacturer
- DENTSPLY GENDEX
- Product Code
- EGY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
SURGERY WAS PERFORMED ON THE WRONG SIDE OF A PATIENT'S MOUTH BECAUSE A PANORAMIC FILM CARTRIDGE WAS PLACED IN THE IMAGING UNIT BACKWARDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DENOPTIX DIGITAL IMAGING SYSTEM | AUTOMATIC RADIOGRAPHIC FILM PROCESSOR | EGY | DENTSPLY GENDEX | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |