BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALC PLUS DISPOSABLE LIGHT HANDLE COVER

    MDR report key: 5635172 · Received May 5, 2016

    Report

    Report Number
    1836161-2016-00031
    Event Type
    Malfunction
    Date Received
    May 5, 2016
    Date of Event
    April 7, 2016
    Report Date
    April 8, 2016
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    FTA
    PMA / PMN Number
    PK020304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE OF THE ENDS OF THE PRODUCT IS SEALED PROPERLY AND THE OTHER END OF THE PRODUCT IS NOT SEALED. SO THE PRODUCT IS NOT STERILE . THE PRODUCT FALLS OUT OF POUCH. SIX INDIVIDUAL POUCHES WERE AFFECTED. THE DEVICE WAS IN THE OPERATING ROOM WHEN THIS OCCURRED. THE PROCEDURE WAS AFFECTED. THE DOCTOR GOT READY TO USE THE PRODUCT AND IT FELL OUT OF POUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290386 ALC PLUS DISPOSABLE LIGHT HANDLE COVER DISPOSABLE LIGHT HANDLE COVER FTA ASPEN SURGICAL PRODUCTS, CALEDONIA LT-ALC01

    Patients

    Seq Age Sex Outcome Treatment
    1