PALETTE EXPANDER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-28 for PALETTE EXPANDER manufactured by .

Event Text Entries

[16558202] My son had systemic toxicity from metal allergies to his braces and palette expander. It started with headaches, stomach aches, then joint pain, bladder pain, flank pain, he collapsed in our home and hit his head, underwent cardiac eval which he was 100% cleared, blood work and when his initial pediatrician wouldn't run a lyme titer i switched pediatricians because i felt like they were missing something. His 2nd and current md did multiple lab tests, x-rays and mri, we took our son to (b)(6) hospital and again his labs were fine, they ran a mono test and told us they thought it was a rheumatology disorder or autoimmune disorder, his skin color was off, he wasn't able to function and missed 15 days of school during this event and many days when i did sens him they would send him home, he was tired, introverted, and a few days could hardly walk, it wasn't until we had hit many walls with no answers that i came up with the thought that "whatever is going on it had to be something different that he was being exposed to". I thought it was from his braces and palette expander and when i started researching online some stories including those of a (b)(6) girl who had braces applied and was found dead in the am from a nickel allergy, i emailed our pediatrician it was a sunday and he said he suspected it was the cause and he needed it removed, we contacted the orthodontist and they removed the braces and palette expander and he was 100% healthy within 48 hours. My concern is why would there be no mandating for nickel allergies before dental appliances are applied? It's a (b)(6) copayment and could save lives. My son was on the brink of death! I am also upset that in nys they only test for 3 metal allergies and wouldn't allow my sons blood to cross state borders when i found other companies that would test him for allergies. Do you have any idea how many metal components he was exposed to? At least 20 if not more, i have obtained the msds. I found a company called (b)(6) and they tested my sons blood for (b)(6) which is not refundable by our insurance and the results are shocking! , please mandate that orthodontics/dentists not only inform pts but mandate allergy testing. My son is allergic to multiple metals and could have died if we hadn't connected the cause. He suffered greatly. He is having trouble with pace for example his reading is about 50% compared to others his age! He doesn't remember much of the time that these appliances were in his mouth. We had a psychological eval completed which was (b)(6) and paid a tutor to work with him at (b)(6) an hour to help him bridge the gaps for all that he has lost. It has been quite an ordeal and i am certain there are others who might have believed it was auto immune or rheumatologic but it didn't site right with me that a perfectly healthy boy could be so very sick. Please mandate a change to save needless suffering. From what i have been explained most people would have had local reactions to the appliances for example-mouth lesions, rash, throat issues etc. My son however suffered and it was attacking his body.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5038921
MDR Report Key4226458
Date Received2014-10-28
Date of Report2014-10-28
Date of Event2014-02-01
Date Added to Maude2014-11-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePALETTE EXPANDER
Generic NamePALETTE EXPANDER
Product CodeDYJ
Date Received2014-10-28
OperatorLAY USER/PATIENT
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2014-10-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.