BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINS/WIRES

    MDR report key: 2821974 · Received October 1, 2012

    Report

    Report Number
    2520274-2012-02107
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    August 31, 2012
    Report Date
    September 3, 2012
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: THE EMAX WAS NOT HOLDING THE WIRE AND IT CONTINUED TO FALL OUT OF THE HANDPIECE. THIS IS 2 OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINS/WIRES HWC

    Patients

    Seq Age Sex Outcome Treatment
    1 EMAX MOTOR| WIRE