FDA Adverse Event
Injury
Summary report: N
ENGINE DRIVEN HEDSTROEM FILE
MDR report key: 2162160
·
Received July 7, 2011
Report
- Report Number
- 8031010-2011-00101
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- May 13, 2011
- Report Date
- June 8, 2011
- Manufacturer
- DENTSPLY TULSA DENTAL SPECIALTIES
- Product Code
- EKS
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THEREFORE, BECAUSE THIS EVENT RESULTED IN A SERIOUS INJURY, IT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT.
Description of Event or Problem · 1
IN THIS EVENT, IT WAS REPORTED THAT A HEDSTROM FILE SEPARATED IN A PATIENT'S MOUTH; AS A RESULT, THE TOOTH WAS EXTRACTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENGINE DRIVEN HEDSTROEM FILE | EKS | DENTSPLY TULSA DENTAL SPECIALTIES | 6343540 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Disability |