BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASYPUMP

    MDR report key: 1812563 · Received August 12, 2010

    Report

    Report Number
    2026095-2010-00110
    Event Type
    Other
    Date Received
    August 12, 2010
    Report Date
    July 19, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. THE SAMPLE WAS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED FOR EVALUATION. WITHOUT THE ACTUAL PRODUCT OR SPECIFIC INFORMATION ON WHAT ACTUALLY OCCURRED, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED, ALTHOUGH REQUESTED. A REVIEW OF THE LOT HISTORY FOUND NO OTHER FAST FLOW COMPLAINTS FOR THE REPORTED LOT. NO DETERMINATION CAN BE MADE FOR THE CONDITION REPORTED AT THIS TIME. IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A F/U REPORT.

    Description of Event or Problem · 1

    FAST FLOW. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYPUMP ELASTOMERIC PUMP MEB I-FLOW CORP. LT-100-48 992808

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK