FDA Adverse Event
Malfunction
Summary report: N
301 ELEV.
MDR report key: 3957488
·
Received June 16, 2014
Report
- Report Number
- 2523190-2014-00045
- Event Type
- Malfunction
- Date Received
- June 16, 2014
- Date of Event
- April 1, 2014
- Report Date
- May 21, 2014
- Manufacturer
- INTEGRA YORK, PA INC.
- Product Code
- DZA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Description of Event or Problem · 1
CUSTOMER INITIALLY REPORTS TIP BROKE. (B)(6) 2014, CUSTOMER REPORTS THE DEVICE WAS BROKEN DURING TOOTH ELEVATION SOMETIME IN APRIL. DOCTOR USES PREVENTIVE MEASURES SO PART WAS NOT SWALLOWED. PART WAS EASILY REMOVED, NO HARM DONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 353010 | 301 ELEV. | M51 - GENERAL DENTISTRY | DZA | INTEGRA YORK, PA INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR |