BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALPHA INFUSION PUMP

    MDR report key: 1880528 · Received October 19, 2010

    Report

    Report Number
    2031920-2009-00004
    Event Type
    Other
    Date Received
    October 19, 2010
    Date of Event
    February 25, 2005
    Report Date
    October 13, 2010
    Manufacturer
    ADVANCED INFUSION, INC.
    Product Code
    MEB
    PMA / PMN Number
    K021964
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2009, AN INFORMAL CLAIM AND "LITIGATION HOLD" WAS DEMANDED FOR A POTENTIAL LAWSUIT THAT MAY BE FILED AGAINST ADVANCED INFUSION, INC., FOR INJURIES SUFFERED AS A RESULT OF THE USE OF AN ADVANCED PAIN PUMP SYS USED ON OR ABOUT (B)(6) 2005. TO DATE NO LAWSUIT HAS BEEN FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA INFUSION PUMP PAIN PUMP MEB ADVANCED INFUSION, INC. A200 04081

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other