BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OP-FLEX SET POOLE X-RAY/350

    MDR report key: 3813475 · Received March 31, 2014

    Report

    Report Number
    3007966929-2014-00012
    Event Type
    Malfunction
    Date Received
    March 31, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 2014
    Manufacturer
    UNOMEDICAL LTD.
    Product Code
    KDC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. IT WAS STATED THE DEVICE WAS NOT USED ON A PATIENT. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FOREIGN OBJECT WAS FOUND (IN THE FORM OF A HAIR) INSIDE THE PRIMER PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189860 OP-FLEX SET POOLE X-RAY/350 INSTRUMENT/SURGICAL, DISPOSABLE KDC UNOMEDICAL LTD. 34070182 655914

    Patients

    Seq Age Sex Outcome Treatment
    1