BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS

    MDR report key: 3980099 · Received August 5, 2014

    Report

    Report Number
    1020279-2014-00482
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    August 9, 2012
    Report Date
    August 1, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    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
    457910 PS GII PS HI FLEX ISRT SZ 3-4 11 JWH SMITH & NEPHEW, INC. 06EM14252

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R 71420999/06FM2325| 71423103/06CM18669A| 71421205/08DM15395| 71420576/06FM16313