FDA Adverse Event
Malfunction
Summary report: N
CARBIDE BURS - FG 557SU
MDR report key: 2871710
·
Received December 11, 2012
Report
- Report Number
- 2523190-2012-00102
- Event Type
- Malfunction
- Date Received
- December 11, 2012
- Report Date
- December 11, 2012
- Manufacturer
- INTEGRA YORK, PA INC.
- Product Code
- EJL
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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 REPORT BURS BREAKING. (B)(6) 2012, CUSTOMER REPORTS THAT IN ONE INSTANCE THEY THINK THE PATIENT SWALLOWED BROKEN PIECE OF BUR BUT WERE NOT SURE AND DID NOT SENT PATIENT FOR X-RAYS. IF THE PATIENT DID SWALLOW THE PIECE THERE HAS BEEN NO EVIDENCE OF HARM TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARBIDE BURS - FG 557SU | M51 - GENERAL DENTISTRY | EJL | INTEGRA YORK, PA INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |