BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 3221843 · Received July 9, 2013

    Report

    Report Number
    1518293-2013-00162
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 13, 2013
    Report Date
    July 9, 2013
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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

    LOST VIDEO. ON (B)(4): PRODUCT MONITORING HAS MADE MULTIPLE ATTEMPTS TO OBTAIN INFO WITHOUT SUCCESS INCLUDING A THIRD ATTEMPT FOR INFO LETTER VIA (B)(6). NO INFO WAS RECEIVED. NO REPORTED INJURY. THE INFIMED HAS BEEN SENT FOR IN HOUSE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313783 HUT EXT DR FINAL ASSY-STANDARD IXR LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK