FDA Adverse Event
Malfunction
Summary report: N
MIRROR - DBL SIDED, SZ 5
MDR report key: 2623525
·
Received June 15, 2012
Report
- Report Number
- 2523190-2012-00051
- Event Type
- Malfunction
- Date Received
- June 15, 2012
- Report Date
- June 15, 2012
- Manufacturer
- MILTEX, INC.
- Product Code
- EAX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem · 1
MIRRORS POPPED OUT. NO PT INJURY. (B)(6) 2012, CUSTOMER REPORTS THE PT COULD HAVE SWALLOWED THE MIRRORS BUT DID NOT. CUSTOMER UNABLE TO SINGLE OUT A PARTICULAR PT OR PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIRROR - DBL SIDED, SZ 5 | M52 - HYGIENE / PERIODONTAL | EAX | MILTEX, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |