BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITH

    MDR report key: 279162 · Received May 25, 2000

    Report

    Report Number
    3022808-2000-00001
    Event Type
    Injury
    Date Received
    May 25, 2000
    Date of Event
    April 15, 2000
    Report Date
    May 24, 2000
    Manufacturer
    BONDET
    Product Code
    HQY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 5/21/2000 RPTR RECEIVED AN E-MAIL FROM PT ADVISING IMPORTER OF THEIR INJURY. PT WAS WEARING A SLIDER 01 SUNGLASS WHILE SKIING. THEY COLLIDED WITH A FELLOW SKIER AND FELL, HITTING THEIR HEAD. THE COLLISION AND FALL CAUSED THE GLASSES TO BREAK AT ONE OF THE TEMPLE PIECES. THE PT RECEIVED A CUT THAT REQUIRED 17 STITCHES. IMPORTER BELIEVES THE CAUSE OF THE INJURY WAS THE COLLISION AND FALL AND NOT A DEFECT IN THE PRODUCT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention