BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F628 MOBILE WITH BATTERY

    MDR report key: 5435484 · Received February 12, 2016

    Report

    Report Number
    0001220865-2016-00007
    Event Type
    Injury
    Date Received
    February 12, 2016
    Date of Event
    January 17, 2016
    Report Date
    January 17, 2016
    Manufacturer
    BERCHTOLD CORP
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER FOR THIS F628 LIGHT HAS BEEN IDENTIFIED AS (B)(4). THIS WAS MISSING DURING THE INITIAL FILING.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DURING THE DISMANTLING OF A F628 ROLL STAND, THE SPRING ARM KICKED BACK AND HIT THE USER IN THE MOUTH. DURING THE DISMANTLE, BREAKDOWN OF THE PRODUCT FOR SHIPMENT, THE SPRING ARM KICKED BACK AND HIT THE USER IN THE MOUTH, RESULTING IN MEDICAL INTERVENTION REQUIRING STITCHES. THE INVESTIGATION SHOWED THAT THERE WAS NO PRODUCT DEFECT AND THE ROOT CAUSE WAS USE ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE DISMANTLING OF A F628 ROLL STAND, THE SPRING ARM KICKED BACK AND HIT THE USER IN THE MOUTH. DUE TO THE INJURY INVOLVED, WE ARE FILING A MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE DISMANTLING OF A F628 ROLL STAND, THE SPRING ARM KICKED BACK AND HIT THE USER IN THE MOUTH. DUE TO THE INJURY INVOLVED, WE ARE FILING A MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90074 F628 MOBILE WITH BATTERY EXAMINATION LIGHT FSY BERCHTOLD CORP

    Patients

    Seq Age Sex Outcome Treatment
    1