BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDINAL HEALTH

    MDR report key: 2987363 · Received February 21, 2013

    Report

    Report Number
    1836161-2013-00086
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    October 15, 2012
    Report Date
    February 21, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    FTA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO TESTING METHODS WERE PERFORMED AS DEVICE WAS NOT RETURNED. NO RESULTS AVAILABLE AS DEVICE WAS NOT RETURNED. DEVICE NOT RETURNED FOR EVAL. 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

    THERE WERE TWO INSTANCES WHERE THE LIGHT HANDLE COVERS FELL OFF ONTO THE PT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75130 CARDINAL HEALTH FLEXIBLE LIGHT HANDLE COVER FTA ASPEN SURGICAL PRODUCTS, INC. 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 Other