BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O. R. CAMERA COVER, STERILE

    MDR report key: 4635373 · Received March 19, 2015

    Report

    Report Number
    1836161-2015-00018
    Event Type
    Malfunction
    Date Received
    March 19, 2015
    Date of Event
    February 27, 2015
    Report Date
    March 19, 2015
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    FTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED: THE HOSPITAL IS CLAIMING THIS LIGHT COVER HAS A BAD LOT WITH HOLES IN THE PACKAGING THAT RENDERS IT UNSTERILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189037 O. R. CAMERA COVER, STERILE O. R. CAMERA COVER STERILE FTA ASPEN SURGICAL PRODUCTS, INC. LT-C01 65391

    Patients

    Seq Age Sex Outcome Treatment
    1