FDA Adverse Event
Injury
Summary report: N
X-RAY EQUIPMENT
MDR report key: 78708
·
Received March 26, 1997
Report
- Report Number
- MW1011044
- Event Type
- Injury
- Date Received
- March 26, 1997
- Date of Event
- July 1, 1993
- Report Date
- March 18, 1997
- Manufacturer
- NI
- Product Code
- IZO
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
RPTR CLAIMS THEY SUFFERED EXCESSIVE IRRADIATION; BURNS, OTHER SKIN PROBLEMS, WITHDRAWAL, AND DEPRESSION AS A RESULT OF AN X-RAY EXAMINATION FOR TMJ. RPTR STATES "AN ATTEMPT WAS MADE TO ENROLL ME IN THEIR FAMILY CARE CLINIC USING FLATTERY. I AM A MEDICAID PARTICIPANT. I BELIEVE DISCRIMINATION, FRAUD, MISREPRESENTATION AND ABUSE OCCURRED. I ALSO BELIEVE THE EQUIPMENT IS FAULTY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | X-RAY EQUIPMENT | X-RAY EQUIPMENT | IZO | NI | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization| L | TYLENOL |