BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISCERA RETAINER

    MDR report key: 540065 · Received August 19, 2004

    Report

    Report Number
    2918699-2004-00002
    Event Type
    Malfunction
    Date Received
    August 19, 2004
    Date of Event
    August 13, 2004
    Report Date
    August 19, 2004
    Manufacturer
    ADEPT-MED INTL., INC.
    Product Code
    GCZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2004 RECEIVED TELEPHONE CALL FROM LAB CONDUCTING PRODUCT TESTING WHICH DREW THE STERILITY OF THE PRODUCT INTO QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISCERA RETAINER VISCERA RETAINER GCZ ADEPT-MED INTL., INC. 3200 11403

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other