MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-03-05 for HILGERS T-REX APPLIANCE * manufactured by Allesee Orthodontic Appliances.
[585452]
In november 2006, a patient alleged that while trying to adjust the hilger t-rex appliance (by turning the screw), a piece of flesh was torn from the inside of her mouth.
Patient Sequence No: 1, Text Type: D, B5
[7920527]
The prescribing doctor did not believe that the appliance was faulty nor caused the injury. The doctor reported that the affected area was healing; however, some redness and tenderness was present. At the request of the patient's mother , the doctor prescribed penicillin.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184045-2007-00001 |
| MDR Report Key | 823818 |
| Report Source | 04 |
| Date Received | 2007-03-05 |
| Date of Report | 2006-11-27 |
| Date of Event | 2006-11-01 |
| Date Mfgr Received | 2006-11-27 |
| Device Manufacturer Date | 2006-09-01 |
| Date Added to Maude | 2007-03-08 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | WENDY URTEL |
| Manufacturer Street | 1717 WEST COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167602 |
| Manufacturer G1 | ALLESEE ORTHODONTIC APPLIANCES |
| Manufacturer Street | 13931 SPRING STREET |
| Manufacturer City | STURTEVANT WI 53177 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HILGERS T-REX APPLIANCE |
| Generic Name | SCREW EXPANSION ORTHODONTIC RETAINER |
| Product Code | DYJ |
| Date Received | 2007-03-05 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | WO# 2407519/9-1-06 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 811220 |
| Manufacturer | ALLESEE ORTHODONTIC APPLIANCES |
| Manufacturer Address | 13931 SPRING ST. STURTEVANT WI 53177 US |
| Baseline Brand Name | HILGERS T-REX APPLIANCE |
| Baseline Generic Name | SCREW EXPANSION ORTHODONTIC RETAINER |
| Baseline Model No | * |
| Baseline Catalog No | * |
| Baseline ID | WO# 2407519/9-1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-03-05 |