FDA Adverse Event
Malfunction
Summary report: N
301 ELEV.
MDR report key: 3964281
·
Received June 19, 2014
Report
- Report Number
- 2523190-2014-00041
- Event Type
- Malfunction
- Date Received
- June 19, 2014
- Date of Event
- June 2, 2014
- Report Date
- June 4, 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 EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem · 1
CUSTOMER INITIALLY REPORTS TIP BROKE DURING USE - NO PT INJURY. ON (B)(6) 2014 DOCTOR REPORTS HE USES PREVENTIVE MEASURES, SO PT CANNOT SWALLOW BROKEN PARTS. PIECE EASILY RETRIEVED FROM GAUZE BARRIER, CONFIRMS NO HARM DONE. DOCTOR CANNOT REMEMBER EXACTLY WHEN THIS EVENT OCCURRED NOR THE AGE/GENDER OF PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360960 | 301 ELEV. | M51 - GENERAL DENTISTRY | DZA | INTEGRA YORK, PA INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |