MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-04-30 for HABIT APPLIANCE manufactured by Allesee Orthodontic Appliances - Connecticut.
[1124460]
In 2009, a doctor reported that a patient had developed a severe rash one day after placement of a metal habit appliance.
Patient Sequence No: 1, Text Type: D, B5
[8391502]
The patient returned to the doctor's office one day after placement of the appliance with a severe rash. The patient's parents informed the doctor that the patient has a known allergy to nickel and possibly other metals. The doctor removed the metal appliance and the patient went to see her pediatric physician. The patient was given three doses of prednisone steroid treatment for eleven days to treat the allergic reaction. Currently, the patient is doing well and is on a prescription antihistamine, atarax, until the rash completely clears. Once the rash has completely cleared, the patient will undergo allergy testing before continuing with the planned orthodontic treatment. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004869383-2009-00001 |
| MDR Report Key | 1372145 |
| Report Source | 05 |
| Date Received | 2009-04-30 |
| Date of Report | 2009-04-02 |
| Date of Event | 2009-04-02 |
| Date Mfgr Received | 2009-04-02 |
| Device Manufacturer Date | 2009-03-27 |
| Date Added to Maude | 2009-05-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. ORLANDO TADEO, JR. |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167419 |
| Manufacturer G1 | ALLESEE ORTHODONTIC APPLIANCES - CONNECTICUT |
| Manufacturer Street | 6 NIBLICK RD |
| Manufacturer City | ENFIELD CT 06082 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06082 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HABIT APPLIANCE |
| Generic Name | RETAINER, SCREW EXPANSION, ORTHODONTIC |
| Product Code | DYJ |
| Date Received | 2009-04-30 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLESEE ORTHODONTIC APPLIANCES - CONNECTICUT |
| Manufacturer Address | 6 NIBLICK RD ENFIELD CT 06082 US 06082 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-04-30 |