BEUDAMED
    FDA Adverse Event Summary report: N

    ACCUPASS

    MDR report key: 3922820 · Received June 10, 2014

    Report

    Report Number
    3922820
    Date Received
    June 10, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 10, 2014
    Manufacturer
    SMITH AND NEPHEW
    Product Code
    HRX
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THE DEVICE HAD BEEN USED ON A PATIENT AND HAS A HOLLOW NEEDLE. IT PUNCTURED THROUGH THE NURSE'S GOWN AND STUCK HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337475 ACCUPASS SUTURE SHUTTLE HRX SMITH AND NEPHEW * 50490075

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR WHILE SCRUBBING FOR A PATIENT'S SHOULDER SURGERY,| SHUTTLE WAS PLACED AND STUCK THE NURSE IN THE| THE NURSE REACHED OVER THE SURGICAL STAND WHERE| THE SMITH AND NEPHEW ACCUPASS DEVICE SUTURE