FDA Adverse Event
Malfunction
Summary report: N
MIRROR - DBL SIDED, SZ 5
MDR report key: 2431946
·
Received January 3, 2012
Report
- Report Number
- 2523190-2012-00001
- Event Type
- Malfunction
- Date Received
- January 3, 2012
- Report Date
- January 3, 2012
- Manufacturer
- INTEGRA YORK, PA INC.
- Product Code
- EAX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- DENTAL HYGIENIST
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Description of Event or Problem · 1
ON (B)(6) 2012, THE DENTAL HYGIENIST REPORTED NUMEROUS MIRRORS HAVE FALLEN APART RECENTLY AND THE STAFF HAS BEEN DISCARDING THEM INTO THE TRASH. SHE STATED ONE OF THE MIRROR SURFACES BECAME UNGLUED AND FELL INTO A PATIENT'S MOUTH WHILE THE HYGIENIST WAS USING IT TO VIEW A LINGUAL SURFACE OF A TOOTH. THERE WAS NO INJURY TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIRROR - DBL SIDED, SZ 5 | M52 - HYGIENE / PERIODONTAL | EAX | INTEGRA YORK, PA INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |