FDA Adverse Event
Injury
Summary report: N
MANDIUBLAR ANTERIOR REPOSITIONING APPLIANCE (MARA)
MDR report key: 1183188
·
Received October 3, 2008
Report
- Report Number
- 2184045-2008-00002
- Event Type
- Injury
- Date Received
- October 3, 2008
- Report Date
- September 5, 2008
- Manufacturer
- ALLESEE ORTHODONTIC APPLIANCES
- Product Code
- KMY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SINCE EACH APPLIANCE IS CUSTOM MADE TO THE REQUEST OF THE PRESCRIPTION THERE WAS NO PRODUCT PROBLEM. THE DOCTOR HAS REQUESTED THAT THE APPLIANCE'S BUCCAL SHIELDS BE CHANGED TO SMALLER SHIELDS FOR PATIENT COMFORT. THE NATURE OF THE PRODUCT WAS IRRITATING THE PATIENT'S CHEEK. THE DOCTOR PRESCRIBED AMOXYCILLIN ANTIBIOTIC TO HELP HEAL THE CHEEK IRRITATION AND THE APPLIANCE WAS REMOVED. THE PATIENT'S ULCERS HAVE NOW COMPLETELY HEALED. THE PATIENT WILL BE FITTED WITH THE MODIFIED APPLIANCE WITH SHORTER BUCCAL SHIELDS AT HIS NEXT APPOINTMENT. THIS IS THE FINAL REPORT. NO DEVICE PROBLEM
Description of Event or Problem · 1
IN 2008, A DOCTOR REPORTED THAT A PATIENT DEVELOPED CHEEK ULCERS DUE TO IRRITATION FROM WEARING THE MARA APPLIANCE AND NEEDED SHORTHER BUCCAL SHIELDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANDIUBLAR ANTERIOR REPOSITIONING APPLIANCE (MARA) | POSITIONER, TOOTH, PREFORMED | KMY | ALLESEE ORTHODONTIC APPLIANCES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |