BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS

    MDR report key: 2980336 · Received February 27, 2013

    Report

    Report Number
    1020279-2013-00125
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 25, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL MDR 1020279-2013-00125 WAS FILED AS BROOKS MANUFACTURING SITE; HOWERVER THIS REPORT SHOULD BE FOR (B)(6) MANUFACTURING SITE, (B)(4).

    Description of Event or Problem · 1

    REVISION SURGERY WAS PERFORMED. THE CAUSE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83760 PS GII PS HI FLEX ISRT SZ 3-4 11 JWH SMITH & NEPHEW, INC. 12KT23907

    Patients

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