FDA Adverse Event
Malfunction
Summary report: N
46 ELEV.
MDR report key: 3964279
·
Received June 19, 2014
Report
- Report Number
- 2523190-2014-00043
- Event Type
- Malfunction
- Date Received
- June 19, 2014
- Report Date
- June 2, 2014
- Manufacturer
- INTEGRA YORK, PA INC.
- Product Code
- GEN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 INFO.
Description of Event or Problem · 1
DEALER INITIALLY REPORTS DEVICE IS BROKEN. ON (B)(6) 2014 ALTHOUGH DEALER HAS RECEIVED THREE EMAILS THERE IS NO RESPONSE TO THE QUESTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360900 | 46 ELEV. | M51 - GENERAL DENTISTRY | GEN | INTEGRA YORK, PA INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |