BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD-PARKER

    MDR report key: 4232481 · Received October 24, 2014

    Report

    Report Number
    1836161-2014-00070
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 24, 2014
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE BLADE BREAKING DURING USE. NO SAMPLES ARE AVAILABLE, LOT NUMBER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678002 BARD-PARKER STAINLESS STEEL BLADES SIZE 10, STERILE GES ASPEN SURGICAL PRODUCTS, INC. 371210

    Patients

    Seq Age Sex Outcome Treatment
    1