BEUDAMED
    FDA Adverse Event Other Summary report: N

    W&H SYNEA 99LT ELECTRIC HANDPIECE

    MDR report key: 2328053 · Received November 2, 2011

    Report

    Report Number
    MW5022988
    Event Type
    Other
    Date Received
    November 2, 2011
    Date of Event
    October 31, 2011
    Report Date
    November 2, 2011
    Manufacturer
    W&H
    Product Code
    EFB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A (B)(4) ELECTRIC HANDPIECE SOLD TO ME BY (B)(4) WAS USED ON A PT WHILE RESTORING TOOTH (B)(6). THE PT STARTED COMPLAINING OF FEELING HEAT ON THE INSIDE OF HIS UPPER RIGHT LIP. I STOPPED THE PROCEDURE, NOTICED A BURN FROM THE BACKSIDE (OPPOSITE THE BUR) OF THE ELECTRIC HANDPIECE ON THE INSIDE OF THE PT'S UPPER RIGHT LIP. I THEN SWITCHED HANDPIECES AND APOLOGIZED IMMEDIATELY TO THE PT. A PICTURE WAS TAKEN FOR EVIDENCE OF THE TRAUMA. I EMAILED THE PICTURE TO (B)(4) WHO FORWARDED THE PICTURE TO A REP FROM (B)(4), WHO SUPPLIES THE HANDPIECE. A REP FROM (B)(4) CALLED ME AND ADMITTED THAT THESE BURNS HAPPEN ALL THE TIME. I ADVISED HIM THAT NO ONE TOLD ME OF THIS WHEN I PURCHASED THE HANDPIECES OR I WOULD NOT HAVE PURCHASED THEM. HE ALSO INFORMED ME THAT THEY WERE NOT WILLING TO ASSIST THE PT FOR HIS TROUBLES. I INFORMED HIM THAT MY PT TRUSTED ME NOT TO HARM HIM AND THAT THE EQUIPMENT NOW HAS HARMED HIM. (B)(4) THEN STATED THAT (B)(4) LAWYERS HAVE IT ALL WORKED OUT. UPON SPEAKING WITH OTHER COLLEAGUES WHO HAVE THE ELECTRIC HANDPIECES, THE SAME THING HAS HAPPENED TO THEM. DATES OF USE: (B)(6) 2010 - (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 W&H SYNEA 99LT ELECTRIC HANDPIECE DENTAL ELECTRIC HANDPIECE EFB W&H 99LT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other