MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-01-07 for DAMON Q manufactured by Ormco Corporation.
[4102777]
An orthodontist alleged that a patient had experienced an allergic reaction to copper and was hospitalized while wearing the damon q brackets and damon copper niti archwire.
Patient Sequence No: 1, Text Type: D, B5
[11472935]
Although the orthodontist identified multiple catalog numbers associated with the incident, no lot numbers were provided; therefore, no catalog numbers or lot numbers were identified in this report. The catalog numbers involved in the alleged incident include one (1) each of catalog numbers 491-6411, 491-6410, 491-6421, 491-6420, 491-6435, 491-6434, 491-6441, 491-6440, 491-6451, 491-6450, 491-6461, 491-6460, 491-6471, 491-6470, 491-6485, 491-6484, 491-6491, 491-6490, 438-2190, 438-2191, 438-0015, and 438-0016. During the hospitalization, the patient was diagnosed with an allergy to copper. The orthodontist described the reaction as "the body was fighting itself". The patient had become very weak and was in a wheelchair when visiting the orthodontist for removal of the brackets and wire. No information with regard to diagnostic testing or prescription medications was provided. The orthodontist reported that the damon q brackets and the damon copper niti archwire were not believed to be the reason for the reaction. The patient did not experience any redness or swelling in the mouth. It was determined by the hospital that the likely cause of the reaction was from copper in the water pipes at home or other domestic sources; however, the damon q brackets and the damon copper niti archwire were removed as a precautionary measure. It was confirmed that the patient has fully recovered and is doing fine. The product was not returned and no lot numbers were provided; therefore, no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2014-00002 |
| MDR Report Key | 3558340 |
| Report Source | 05 |
| Date Received | 2014-01-07 |
| Date of Report | 2013-12-11 |
| Date Mfgr Received | 2013-12-11 |
| Date Added to Maude | 2014-01-07 |
| 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 | MRS. KERRI CASINO |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167634 |
| Manufacturer G1 | ORMCO CORPORATION |
| Manufacturer Street | 1332 SOUTH LONE HILL AVENUE |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91740 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAMON Q |
| Generic Name | BRACKET, METAL, ORTHODONTIC |
| Product Code | DYW |
| Date Received | 2014-01-07 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2014-01-07 |