FDA.reportPublic FDA data

MAUDE MDR 3558339

MDR report key
3558339
Report number
2016150-2014-00001
Event key
0
Event type
3
Date received
2014-01-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MRS. KERRI CASINO
Address
1717 W COLLINS AVE ORANGE CA 92867 US
Phone
714-714-7145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DAMON COPPER NITI WIREWIRE, ORTHODONTICORMCO CORPORATIONDZC205-1909R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-01-0701. H; 2. O; 3. R

Event Narratives#

D

Patient 1

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.

N

Patient 1

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.