BEUDAMED
    FDA Adverse Event Other Summary report: N

    GO PUMP RAPID RECOVERY SYSTEM

    MDR report key: 2625774 · Received May 31, 2012

    Report

    Report Number
    3005203102-2012-00004
    Event Type
    Other
    Date Received
    May 31, 2012
    Date of Event
    May 15, 2012
    Report Date
    May 22, 2012
    Manufacturer
    SYMBIOS MEDICAL PRODUCTS
    Product Code
    MEB
    PMA / PMN Number
    K072921
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CATHETER WAS BROKEN BY THE PT WHEN THEY WERE MOVING AROUND AND ATTEMPTED TO GET OUT OF BED. IT WAS REPORTED THE PT "CAUGHT" THE TUBING AND BROKE THE CATHETER. AN X-RAY WAS TAKEN TO ASSESS WHAT PATH TO TAKE WITH REGARD TO REMOVAL. CONSEQUENTLY, THE REMAINING PIECE WAS SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GO PUMP RAPID RECOVERY SYSTEM MEB, BSO, KGZ MEB SYMBIOS MEDICAL PRODUCTS 510551-BP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention