Description of Event or Problem · 1
ON 10/11/93 THE DENTIST PLACED AN ORTHODONTIC APPLIANCE INTO A 4-YR-OLD GIRL'S MOUTH. THIS DEVICE WAS INSERTED TO STOP THUMB SUCKING. THE DEVICE IS A METAL PLATE WHICH IS PERMANENTLY APPLIED TO THE ROOF OF THE MOUTH. THE DENTIST TOLD THE MOTHER THAT THE PLATE WAS MADE OF 100% STAINLESS STEEL AND WAS NON-TOXIC AND SAFE. ON 10/12/93, CHILD BEGAN VOMITING AND HER JOINTS BECAME STIFF AND SWOLLEN. THAT AFTERNOON MOTHER TOOK THE CHILD TO THE DR WHO ADMITTED THE CHILD INTO HOSP THE FOLLOWING MORNING. THE CHILD'S SYMPTOMS AT THIS TIME INCLUDED: FEVER (101), PURPLE/RED RASH, SWOLLEN AND STIFF JOINTS, AND SWOLLEN LYMPH NODES. THE CHILD WAS DIAGNOSED WITH KAWASAKI DISEASE, BUT LATER DRS DETERMINED THE SYMPTOMS TO BE DUE TO AN ALLERGIC REACTION TO THE ORTHODONTIC PLATE. ON 10/16/93, THE DENTIST REMOVED THE ORTHODONTIC PLATE FROM THE CHILD'S MOUTH DUE TO THE MOTHER'S REQUEST. SIX HRS LATER THE CHILD'S SYMPTOMS BEGAN TO DISAPPEAR. TWENTY-FOUR HRS LATER, THE CHILD WAS RELEASED FROM THE HOSP. SINCE THE ABOVE INCIDENT THE MOTHER HAS OBTAINED MSDS SHEETS FROM THE PLATE'S DISTRIBUTOR. THE MSDS SHEETS STATED THAT THE METAL (SILVER, TIN, COPPER, AND ZINC) WAS TOXIC AND SHOULD NOT BE USED TO MFR ITEMS THAT HAVE PHYSICAL CONTACT WITH HUMAN TISSUE. PT'S MOTHER HAS THE DEVICE IN HER POSSESSION.