BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2894973 · Received November 15, 2007

    Report

    Report Number
    1833497-2007-00004
    Event Type
    Malfunction
    Date Received
    November 15, 2007
    Product Code
    UNK
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY HAS NOT PROVIDE ANY INFO ABOUT THIS INCIDENT. AFTER NUMEROUS CALLS TO FACILITY, INITIAL REPORTER NO LONGER WORKS AT THE FACILITY. SPOKE WITH ADMINISTRATOR AND ASKED FOR INFO AND SHE REFUSED TO SENT INCIDENT REPORT. ALSO WAS UNABLE TO GET SERIAL NUMBER OR MODEL. UNK IF THIS DEVICE IS MANUFACTURED BY INNOVATIVE PRODUCTS UNLIMITED, INC. REF: FDA LETTER (B)(4).

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1