BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHARD ALLAN

    MDR report key: 3012695 · Received February 22, 2013

    Report

    Report Number
    1836161-2013-00045
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    April 13, 2011
    Report Date
    February 22, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO A RECENT FDA INSPECTION, THIS MDR IS BEING REPORTED LATE AS A RESULT OF A RE-EVALUATION.

    Description of Event or Problem · 1

    THE NEEDLES HAVE BEEN BROKEN 3 TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78770 RICHARD ALLAN SURGICAL BLADE #15 GES ASPEN SURGICAL PRODUCTS, INC. 2016-01-17

    Patients

    Seq Age Sex Outcome Treatment
    1