BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 483020 · Received September 5, 2003

    Report

    Report Number
    MW1029448
    Event Type
    Injury
    Date Received
    September 5, 2003
    Date of Event
    June 6, 2000
    Report Date
    September 5, 2003
    Manufacturer
    *
    Product Code
    EIE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT WAS REFERRED BY THEIR REGULAR DENTIST TO HAVE A ROOT CANAL DONE FOR CHRONIC ABSCESS IN 2000. PT CAME OUT WITH A TRAUMATIC DISLOCATION OF THE JAW, WHICH WAS CONFIRMED BY AN MRI. UPON REVIEW IT WAS THOUGHT THAT IT WOULD HEAL ON ITS OWN. A MOUTH PLATE WAS INTRODUCED IN NOVEMBER 2000 BUT HAD TO STOP AFTER 6 MONTHS BECAUSE IT DID NOT HELP. IN 2001 AND 2003 NEEDLES WRE PUT IN THE JAW TO MANIPULATE IT BACK TO POSITION BUT THERE WAS NO RELIEF. THEY WERE ASKED TO SEE A PHYSICAL THERAPIST BUT THERE HAS BEEN NO IMPROVEMENT. THE ROOT CANAL HAD BEEN RE-DONE DURING WHICH A TOOTH GOT BROKEN AND HAD TO BE CROWNED. THEY HAVE SCARS ON THEIR FACE AND HAVE BEEN ON PAIN MEDICATION (TEGRETOL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * RUBBER DAM EIE * UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention