BEUDAMED
    FDA Adverse Event Injury Summary report: N

    W&H WA-99LT DENTAL HANDPIECE

    MDR report key: 794130 · Received December 7, 2006

    Report

    Report Number
    MW1041286
    Event Type
    Injury
    Date Received
    December 7, 2006
    Date of Event
    May 22, 2006
    Report Date
    November 21, 2006
    Manufacturer
    W&H DENTALWERK BIIMOOS GMBH
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BURNED PT'S MOUTH, DOCTOR OUT PT ON STEROIDS TO HELP HEAL BURN. BURN CAUSED BY WA-99LT ATTACHED TO ELECTRIC MICROMOTOR DURING DENTAL PROCEDURE. PROBLEM: WA-99LT HANDPIECE ATTACHMENT RETURNED FOR EVALUATION. HEAD ASSEMBLY DOES NOT TURN, HEAD GEAR IS WORN/DAMAGED. BOTH HEAD GEAR BEARING ASSEMBLIES ARE BROKEN. BALL BEARINGS ARE DARK AND DULL, HEAD CAP IS CONTAMINATED WITH BEARING CAGE MATERIAL. MIDDLE GEARS ARE WORN, DRIVE SHAFT WORN, BEARINGS ARE GRITTY. PRODUCT USE ERROR: FAILURE TO MAINTAIN HANDPIECE ACCORDING TO IFU. DOCTOR SENT MAINTENANCE LETTER REMINDER AND TECHNICAL SERVICE LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 W&H WA-99LT DENTAL HANDPIECE 1:5 HANDPIECE ATTACHMENT EFB W&H DENTALWERK BIIMOOS GMBH WA-99LT *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention