BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITH

    MDR report key: 189680 · Received September 30, 1998

    Report

    Report Number
    3022808-1998-00002
    Event Type
    Injury
    Date Received
    September 30, 1998
    Date of Event
    September 1, 1998
    Report Date
    September 30, 1998
    Manufacturer
    BONDET
    Product Code
    HQZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 9/30/98 DIST REC'D A LETTER ADVISING OF THE INJURY. PT WAS WEARING SLIDER SL2 SUNGLASSES WHILE RIDING HIS MOUNTAIN BIKE. HE FELL AND HIT THE GROUND BREAKING THE FRAME OF THE GLASSES. HE REC'D A CUT THAT REQUIRED 9 STITCHES. DIST BELIEVES THE INJURY WAS CAUSED BY THE PERSON FALLING AND NOT BY THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMITH SUNGLASSES HQZ BONDET * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention