FDA Adverse Event
Malfunction
Summary report: N
MINIATURE PIN & LIGATURE CUTTER
MDR report key: 2264988
·
Received August 17, 2011
Report
- Report Number
- 2086211-2011-00004
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Report Date
- July 18, 2011
- Manufacturer
- GAC INTERNATIONAL
- Product Code
- EJB
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT REC'D IN THE PAST TWO YRS INVOLVING A SIMILAR DEVICE WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVAL, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVAL RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.
Description of Event or Problem · 1
IN THIS EVENT IT WAS REPORTED THAT THE TIP OF A MINIATURE PIN AND LIGATURE CUTTER SEPARATED OUTSIDE OF A PT'S MOUTH; THERE IS NO INDICATION THAT INJURY RESULTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINIATURE PIN & LIGATURE CUTTER | EJB | GAC INTERNATIONAL | 09-22-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LIG WIRE (SMALL)| CHAIN LIGS |