BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2883153 · Received December 18, 2012

    Report

    Report Number
    1518293-2012-00238
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    December 10, 2012
    Report Date
    December 18, 2012
    Manufacturer
    LIEBEL-FLARSHEIM BUSINESS
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS VIA PHONE THE PHYSICIST EVALUATION FOUND THE MAX R/MIN TO EXCEED 10R. PHYSICIST SHOWS 11.4R/MIN AT 30PPI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUT EXT DR FINAL ASSY-REVERSE IXR LIEBEL-FLARSHEIM BUSINESS HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK