FDA Adverse Event
Injury
Summary report: N
DISTAL JET
MDR report key: 2403077
·
Received January 7, 2012
Report
- Report Number
- 2184045-2012-00003
- Event Type
- Injury
- Date Received
- January 7, 2012
- Report Date
- December 9, 2011
- Manufacturer
- ALLESEE ORTHODONTIC APPLIANCES
- Product Code
- DYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DOCTOR PRESCRIBED AN ANTIBIOTIC AND BENADRYL FOR THE ALLEGED ALLERGIC REACTION. TO DATE, THE PATIENT IS DOING FINE AND HAS FULLY RECOVERED. A NEW APPLIANCE WILL BE REMADE WITH A DIFFERENT MATERIAL WITH REGARD TO PATIENT COMFORT.
Description of Event or Problem · 1
ON (B)(6), 2011, A DOCTOR ALLEDGED THAT A PATIENT POSSIBLY HAD AN ALLERGIC REACTION TO THE DISTAL JET APPLIANCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISTAL JET | RETAINER, SCREW EXPANSION, ORTHODONTIC | DYJ | ALLESEE ORTHODONTIC APPLIANCES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |