FDA Adverse Event
Injury
Summary report: N
HERBST APPLIANCE
MDR report key: 931657
·
Received October 24, 2007
Report
- Report Number
- 2184045-2007-00003
- Event Type
- Injury
- Date Received
- October 24, 2007
- Report Date
- September 26, 2007
- Manufacturer
- ALLESEE ORTHODONTIC APPLIANCES
- Product Code
- DYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS ALLEGED INCIDENT AND THE USE OF THE HERBST APPLIANCE COULD NOT BE CONFIRMED. THE COMPLAINANT (THE ALLEGED PT'S MOTHER) WOULD NOT DISCLOSE THE NAME OF THE TREATING ORTHODONTIST TO CONFIRM THE USE OF THE HERBST APPLIANCE. ADDITIONALLY, THE PT COULD NOT BE LOCATED IN ALLESEE ORTHODONTIC APPLIANCE'S PT DATABASE.
Description of Event or Problem · 1
IN 2007, A PT'S PARENT ALLEGED THAT HALF OF THE PT'S TOOTH BROKE OFF WHEN THE ORTHODONTIST REMOVED THE HERBST APPLIANCE DURING ORTHODONTIC TREATMENT.
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 | Other |