MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-05-12 for UNK manufactured by 3m Unitek.
[20293984]
Adult female undergoing orthodontic treatment had an allergic reaction following the bonding of metal bands, tubes and brackets to her teeth. The allergic reaction was reported by the orthodontist as serious, and info about the nickel content in the stainless steel appliances was requested. 3m provided the response that these appliances all contain nickel and chromium, and that the product is labeled with a warning directing the pt to consult a physician if an allergic reaction occurs. 3m also recommended the removal of the appliances if the pt was confirmed to have an allergy to nickel/chromium. Further info from reporter revealed that the pt had a small allergic reaction after the first step of her treatment, but decided to continue treatment and had a massive allergic reaction including lack of consciousness and fever which resulted in hospitalization. The doctor suggested removal of the appliances but the pt refused. She is currently on steroids treatment. The doctor declined to provide info about the pt or identify the hosp.
Patient Sequence No: 1, Text Type: D, B5
[20503080]
The doctor could not provide the lot number or name of the appliances used on this pt. He did not purchase the product directly from 3m. The product had been repacked, but he was certain they were 3m products, though he was unable to provide the brand name.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020467-2014-00001 |
| MDR Report Key | 3830134 |
| Report Source | 01,07 |
| Date Received | 2014-05-12 |
| Date of Report | 2014-04-18 |
| Date of Event | 2014-04-01 |
| Date Mfgr Received | 2014-04-18 |
| Date Added to Maude | 2014-05-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHLEEN 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 | UNK |
| Generic Name | ORTHODONTIC METAL BRACKET, BAND, TUBE, - EJF, ECM, DZD |
| Product Code | EJF |
| Date Received | 2014-05-12 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | MONROVIA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-05-12 |