BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYSTAL AIRWAY MASK

    MDR report key: 4551593 · Received February 20, 2015

    Report

    Report Number
    MW5040938
    Event Type
    Malfunction
    Date Received
    February 20, 2015
    Report Date
    February 20, 2015
    Manufacturer
    KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRODUCT IS BEING IMPORTED AND DISTRIBUTED THAT IS PAST EXPIRY DATE ON PRODUCT LABEL. EXPIRY DATE IS NOT LISTED ON PRODUCT SHIPPER. (B)(6). DISTRIBUTOR CONTACTED AND NO RECALL NOTICE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122161 CRYSTAL AIRWAY MASK DISPOSABLE LARYNGEAL MASK CAE KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD KM-817 0906181B

    Patients

    Seq Age Sex Outcome Treatment
    1