BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 295744 · Received September 5, 2000

    Report

    Report Number
    MW1019888
    Event Type
    Injury
    Date Received
    September 5, 2000
    Date of Event
    March 27, 2000
    Report Date
    August 28, 2000
    Manufacturer
    UNK
    Product Code
    EKK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BEGAN EXPERIENCING NUMBNESS AND PAIN BELOW A TOOTH IN WHICH RPTR HAD A ROOT CANAL DONE IN A NUMBER OF YEARS AGO. THE NUMBNESS RADIATED OUT TO COMPLETE JAW AREA, LIPS, AND TONGUE. AN ENDODONTIST ATTEMPTED A RETREATMENT OF THE TOOTH WHICH WAS UNSUCCESSFUL AND TOOTH WAS EXTRACTED. NUMBNESS INCREASED TO JAW AREAS. NUMBNESS STILL PERSISTS AFTER 5 MONTHS. THIS WRITER FEELS UNSAFE ENDODONTIC MATERIALS WERE USED AND THESE MATERIALS LEECHED INTO BLOOD STREAM AFTER TOOTH DETERIORATED CAUSING PARETHESIA AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NA EKK UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Disability