BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1020279-2013-00212

    MDR report key: 3060193 · Received April 16, 2013

    Report

    Report Number
    1020279-2013-00212
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    November 15, 2012
    Report Date
    April 5, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163384 JWH SMITH & NEPHEW, INC. 01KM10279

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R 71420182/02CM09842| 71420490/02CT67732