FDA Adverse Event
Injury
Summary report: N
HERBST
MDR report key: 3093893
·
Received May 6, 2013
Report
- Report Number
- 2184045-2013-00005
- Event Type
- Injury
- Date Received
- May 6, 2013
- Report Date
- April 16, 2013
- Manufacturer
- ALLESEE ORTHODONTIC APPLIANCES
- Product Code
- EJF
- PMA / PMN Number
- K923405
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A NEW CROWN WAS PLACED FOR THE PATIENT BY A DENTIST, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE AND HAS FULLY RECOVERED. A NEW APPLIANCE WILL BE FABRICATED WITH CONSIDERATION TO PATIENT COMFORT. A VISUAL EVALUATION WAS PERFORMED ON THE RETURNED DEVICE, YIELDING RESULTS WITHIN SPECIFICATIONS.
Description of Event or Problem · 1
A DOCTOR'S OFFICE ALLEGED THAT WHILE REMOVING THE HERBST APPLIANCE A PATIENT HAD EXPERIENCED THE LOSS OF A CROWN, WHICH HAD ATTACHED TO IT AN AMALGAM RESTORATION AND SOME OF THE PATIENT'S NATURAL DENTITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 195904 | HERBST | BITE-JUMPING ORTHODONTIC APPLIANCE | EJF | ALLESEE ORTHODONTIC APPLIANCES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |