BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS

    MDR report key: 3191484 · Received June 26, 2013

    Report

    Report Number
    8010764-2013-00032
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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
    291471 PS GII PS HI FLEX ISRT SZ 5-6 9 JWH SMITH & NEPHEW, INC. 12AT14093

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R (B)(4)| (B)(4)