BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD-PARKER

    MDR report key: 6069078 · Received November 1, 2016

    Report

    Report Number
    6069078
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    October 20, 2014
    Report Date
    October 3, 2016
    Manufacturer
    ASPEN SURGICAL PUERTO RICO CORP.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGICAL TECHNICIAN WAS LOADING A SAFETY BLADE ON A KNIFE HANDLE. THE MECHANISM MALFUNCTIONED AND THE BLADE WENT THROUGH INJURING THE TECHNICIAN WITH A PUNCTURE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719773 BARD-PARKER BLADE, SCALPEL GES ASPEN SURGICAL PUERTO RICO CORP. 0102833

    Patients

    Seq Age Sex Outcome Treatment
    1