BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GII CR

    MDR report key: 2770049 · Received October 3, 2012

    Report

    Report Number
    1020279-2012-00549
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    SMITH & NEPHEW, INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GII CR GII OXINIUM FEM SIZE 5 LEFT JWH SMITH & NEPHEW, INC 12AM03941

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention (B)(4)