BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR

    MDR report key: 2910986 · Received January 11, 2013

    Report

    Report Number
    1020279-2013-00022
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO DISASSOCIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16261 CR GII CR DEEP FLEX ISRT S3-4 9M JWH SMITH & NEPHEW, INC. 12JM08607

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention