MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-05-09 for APC PLUS, CLARITY, MINI UNI-TWIN, VICTORY SERIES 5020-XXX, 6800-XXX manufactured by 3m Unitek.
[2762979]
Pt had an allergic reaction to her orthodontic brackets and adhesive. First the upper arch was bonded with ceramic brackets, which caused a slight allergic reaction. At the next appointment the lower arch was bonded with stainless steel brackets, which caused a greater allergic reaction. The orthodontist had to remove all of the brackets. Pt was referred to a physician, according to product warning recommendation. Pt was found to be allergic to the metal and adhesive. No medication was prescribed for the allergic reaction. Parent preferred homeopathic treatment.
Patient Sequence No: 1, Text Type: D, B5
[9925565]
Applicable 510(k)s: k020394, k944286. Labels for adhesive-coated brackets display the following warning: possible acrylic sensitivity. Labels of stainless steel brackets and buccal tubes display the following warning: this product contains nickel and/or chromium. A small percentage of the population is known to be allergic to nickel and/or chromium. If an allergic reaction occurs, direct pt to consult a physician.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020467-2012-00001 |
| MDR Report Key | 2622884 |
| Report Source | 05 |
| Date Received | 2012-05-09 |
| Date of Report | 2012-05-08 |
| Date of Event | 2012-03-01 |
| Date Mfgr Received | 2012-03-08 |
| Date Added to Maude | 2012-06-21 |
| 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 | LATHLEEN BACON |
| Manufacturer Street | 2724 SOUTH PECK RD. |
| Manufacturer City | MONROVIA CA 91016 |
| Manufacturer Country | US |
| Manufacturer Postal | 91016 |
| Manufacturer Phone | 6265744212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APC PLUS, CLARITY, MINI UNI-TWIN, VICTORY SERIES |
| Generic Name | ORTHODONTIC ADHESIVE, BRACKETS, TUBES |
| Product Code | DYH |
| Date Received | 2012-05-09 |
| Model Number | NA |
| Catalog Number | 5020-XXX, 6800-XXX |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK RD. MONROVIA CA 91016 US 91016 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-05-09 |