BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KING SEPTEMS

    MDR report key: 2821123 · Received November 1, 2012

    Report

    Report Number
    MW5027459
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    KING SEPTEMS
    Product Code
    LMA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    KING SEPTEMS REF NUMBER LAD-304 LOT NUMBER: K120619. KING SEPTEMS REFERENCE NUMBER: LAD-303 LOT- K120618. PRODUCTS LABELED AS STERILE BUT COLOR CHANGE INDICATORS DO NOT REFLECT STERILITY. SPOKE WITH (B)(6) OFFICE, COORDINATOR WHO INSTRUCTED THAT THE OFFICE WOULD NOT COLLECT THE PRODUCTS. AS SUCH, WE HAVE RETURNED THEM TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KING SEPTEMS LMA KING SEPTEMS LAD304 K120619
    2 KING SEPTEMS LMA KING SEPTEMS LAD303 K120618

    Patients

    Seq Age Sex Outcome Treatment
    1