FDA Adverse Event
Injury
Summary report: N
HERBST
MDR report key: 2494923
·
Received March 16, 2012
Report
- Report Number
- 2184045-2012-00005
- Event Type
- Injury
- Date Received
- March 16, 2012
- Report Date
- February 15, 2012
- Manufacturer
- ALLESEE ORTHODONTIC APPLIANCES
- Product Code
- EJF
- PMA / PMN Number
- K923405
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PATIENT WAS PRESCRIBED CHLORHEXIDINE, AN ANTISEPTIC RINSE, FOR TREATMENT. PATIENT IS DOING FINE AND HAS FULLY RECOVERED. THE AXLE CASING ON THE UPPER APPLIANCE WILL BE REPOSITIONED WITH CONSIDERATION TO PATIENT COMFORT.
Description of Event or Problem · 1
THE CUSTOMER STATED THAT THE UL BAND OF THE HERBST APPLIANCE WAS CUTTING INTO THE PATIENT'S CHEEKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HERBST | BITE-JUMPING ORTHODONTIC APPLIANCE | EJF | ALLESEE ORTHODONTIC APPLIANCES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Other |