FDA Adverse Event
Malfunction
Summary report: N
MIRROR - DBL SIDED, SZ 5
MDR report key: 2577552
·
Received May 10, 2012
Report
- Report Number
- 2523190-2012-00049
- Event Type
- Malfunction
- Date Received
- May 10, 2012
- Report Date
- May 10, 2012
- Manufacturer
- INTEGRA YORK, INC
- Product Code
- EAX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem · 1
DOCTOR REPORTED VIA PHONE THAT THE MIRROR FELL OFF IN THE PT'S MOUTH AND WAS RETRIEVED BUT COULD HAVE BEEN SWALLOWED, NO PT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIRROR - DBL SIDED, SZ 5 | M52-HYGIENE/PERIODONTAL | EAX | INTEGRA YORK, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |