MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-08-19 for APC II MINIATURE TWIN METAL BRACKET 3017-XXX manufactured by 3m Unitek.
[21715511]
Patient experienced an allergic reaction shortly after beginning orthodontic treatment. A dermatologist determined that patient is allergic to nickel and bleaching agents. Treatment for patient's allergic reaction included removal of the orthdontic appliances and a prescription steroid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2005-00006 |
| MDR Report Key | 628642 |
| Report Source | 05 |
| Date Received | 2005-08-19 |
| Date of Report | 2005-08-04 |
| Date of Event | 2005-07-16 |
| Date Mfgr Received | 2005-08-04 |
| Date Added to Maude | 2005-08-23 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARLYN SCHEFF |
| Manufacturer Street | 2724 SOUTH PECK ROAD |
| Manufacturer City | MONROVIA CA 91016 |
| Manufacturer Country | US |
| Manufacturer Postal | 91016 |
| Manufacturer Phone | 6265744496 |
| Manufacturer G1 | 3M UNITEK |
| Manufacturer Street | 2724 SOUTH PECK ROAD |
| Manufacturer City | MONROVIA CA 91016 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91016 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APC II MINIATURE TWIN METAL BRACKET |
| Generic Name | ORTHODONTIC METAL BRACKET |
| Product Code | DYW |
| Date Received | 2005-08-19 |
| Model Number | NA |
| Catalog Number | 3017-XXX |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 618259 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK ROAD MONROVIA CA 91016 US |
| Baseline Brand Name | APC II MINIATURE TWIN METAL BRACKET |
| Baseline Generic Name | ORTHODONTIC METAL BRACKET |
| Baseline Model No | NA |
| Baseline Catalog No | 3017-XXX |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-08-19 |