BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.R. CAMERA COVER, STERILE

    MDR report key: 7068561 · Received November 29, 2017

    Report

    Report Number
    1836161-2017-00120
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    November 1, 2017
    Report Date
    November 29, 2017
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    KQM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING SAMPLE CONFIRMATION.

    Description of Event or Problem · 1

    PACKAGE OF STERILE OR CAMERA COVER LT-C02 WAS FOUND OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848970 O.R. CAMERA COVER, STERILE CAMERA COVER KQM ASPEN SURGICAL PRODUCTS, CALEDONIA LT-C02 141733

    Patients

    Seq Age Sex Outcome Treatment
    1