BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN

    MDR report key: 20843640 · Received December 4, 2024

    Report

    Report Number
    3011300255-2024-00007
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    October 15, 2024
    Report Date
    December 4, 2024
    Manufacturer
    W&H DENTALWERK BUERMOOS GMBH
    Product Code
    EFB
    UDI-DI
    00304040153857
    PMA / PMN Number
    K162926
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    3007007357-2024-00024 AFTER INVESTIGATION, NO DEFECT WAS FOUND, THE OVERHEATING COULD NOT BE REPRODUCED. THE CONTRA-ANGLE HANDPIECE WAS WELL MAINTAINED ON THE OUTSIDE AND INSIDE AND WORKS PERFECTLY.

    Description of Event or Problem · 0

    DEVICE WAS OVER HEATING DURING TREATMENT OF PATIENT. NO INJURIES OR BURNS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850092 HENRY SCHEIN DENTAL HANDPIECE EFB W&H DENTALWERK BUERMOOS GMBH MAXIMA ELITE 2 CA 00304040153857

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other