DAMON Q

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number2016150-2014-00002
MDR Report Key3558340
Report Source05
Date Received2014-01-07
Date of Report2013-12-11
Date Mfgr Received2013-12-11
Date Added to Maude2014-01-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMRS. KERRI CASINO
Manufacturer Street1717 W COLLINS AVE
Manufacturer CityORANGE CA 92867
Manufacturer CountryUS
Manufacturer Postal92867
Manufacturer Phone7145167634
Manufacturer G1ORMCO CORPORATION
Manufacturer Street1332 SOUTH LONE HILL AVENUE
Manufacturer CityGLENDORA CA 91740
Manufacturer CountryUS
Manufacturer Postal Code91740
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDAMON Q
Generic NameBRACKET, METAL, ORTHODONTIC
Product CodeDYW
Date Received2014-01-07
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerORMCO CORPORATION
Manufacturer Address1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other; 3. Required No Informationntervention 2014-01-07

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