BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASERFLO

    MDR report key: 76826 · Received March 17, 1997

    Report

    Report Number
    2183929-1997-00001
    Event Type
    Injury
    Date Received
    March 17, 1997
    Date of Event
    February 11, 1997
    Report Date
    March 10, 1997
    Manufacturer
    VASAMEDICS L.L.C.
    Product Code
    DPW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 2/11/97 THE BLOOD PERFUSION MONITOR WAS USED POST OPERATIVELY TO MEASURE BLOOD FLOW ON A MUSCLE FLAP TRANSPLANT ON A 39 YR OLD MALE PT. THE MUSCLE FLAP FAILED YET THE MONITOR INDICATED SOME BLOOD FLOW. THE MONITOR WAS TESTED AT THE PLASTIC SURGERY LAB IMMEDIATELY AFTER THE CASE WITH NO TROUBLE FOUND. THE MONITOR HAS NOT YET BEEN RETURNED TO THE MFR FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASERFLO LASER DOPPLER BLOOD FLOW MONITOR DPW VASAMEDICS L.L.C. BPM2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| O