MAUDE Adverse Event Report: ORMCO CORPORATION DAMON COPPER NITI WIRE; WIRE, ORTHODONTIC

Catalog Number 205-1909

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

An orthodontist alleged that a patient had experienced an allergic reaction to copper and was hospitalized while wearing the damon cuniti wire with damon q brackets.

Manufacturer Narrative

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 cuniti archwire and the damon q brackets 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 cuniti archwire and the damon q brackets 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 number was provided; therefore, no evaluation can be conducted.

• Brand Name: DAMON COPPER NITI WIRE
• Type of Device: WIRE, ORTHODONTIC
• Manufacturer (Section D): ORMCO CORPORATION; 1332 south lone hill avenue; glendora CA 91740
• Manufacturer (Section G): ORMCO CORPORATION; 1332 south lone hill avenue; glendora CA 91740
• Manufacturer Contact: kerri casino ; 1717 w collins ave; orange, CA 92867 ; 7145167634
• MDR Report Key: 3558339
• MDR Text Key: 4077936
• Report Number: 2016150-2014-00001
• Device Sequence Number: 1
• Product Code: DZC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 205-1909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2013
• Initial Date FDA Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DAMON Q
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 12 YR