BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDINAL HEALTH

    MDR report key: 2979883 · Received February 22, 2013

    Report

    Report Number
    1836161-2013-00081
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    August 6, 2012
    Report Date
    February 22, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    FTA
    PMA / PMN Number
    K020304
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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

    BLADE DIFFICULT TO REMOVE FROM PACK, PACK SEEMS TO BE REALLY FLAT. ONE NURSE WAS CUT TRYING TO REMOVE THE BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78595 CARDINAL HEALTH LIGHT HANDLE COVER FTA ASPEN SURGICAL PRODUCTS, INC. 10700

    Patients

    Seq Age Sex Outcome Treatment
    1 Other