FDA Adverse Event
Injury
Summary report: N
HERBST APPLIANCE
MDR report key: 861549
·
Received June 7, 2007
Report
- Report Number
- 2184045-2007-00002
- Event Type
- Injury
- Date Received
- June 7, 2007
- Date of Event
- April 1, 2007
- Report Date
- May 9, 2007
- Manufacturer
- ALLESEE ORTHODONTIC APPLIANCES
- Product Code
- DYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DR REPAIRED THE PT'S DAMAGED CROWN. THE HERBST APPLIANCE WAS REPAIRED AND RETURNED TO THE DR FOR PLACEMENT.
Description of Event or Problem · 1
IN 5/07, THE DR INFORMED ALLESEE ORTHODONTIC APPLIANCES THAT THE TISSUE IN THE PT'S MOUTH HAD SWOLLEN AROUND THE CANTILEVER OF A PREVIOUSLY BROKEN HERBST APPLIANCE. THE DR HAD TO CUT A SMALL HOLE IN THE PT'S CROWN IN ORDER TO REMOVE THE DEVICE FOR REPAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HERBST APPLIANCE | BITE-JUMPING ORTHODONTIC APPLIANCE | DYJ | ALLESEE ORTHODONTIC APPLIANCES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |