BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITH

    MDR report key: 119154 · Received September 12, 1997

    Report

    Report Number
    3022808-1997-00003
    Event Type
    Injury
    Date Received
    September 12, 1997
    Report Date
    September 12, 1997
    Manufacturer
    BONEDT
    Product Code
    HQY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON SEPTEMBER 12, 1997 THE DISTRIBUTOR REC'D A LETTER FROM THE COMPLAINANT ADVISING THE DIST. OF THE INJURY. THE COMPLAINANT WAS WEARING SLIDER AB3 SUNGLASSES WHILE RIDING HER MOUNTAIN BIKE. SHE FELL AND HIT HER FACE ON A ROCK. THE NOSE PIECE BROKE OFF AND SHE STATES IT CAUSED A CUT REQUIRING 20 STITCHES. THE DISTRIBUTOR BELIEVES THE INJURY WAS CAUSED BY THE PERSON FALLING ON HER FACE AND NOT BY THE DIST'S PRODUCT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention