BEUDAMED
    FDA Adverse Event Summary report: N

    BIOMEDIX

    MDR report key: 811227 · Received January 31, 2007

    Report

    Report Number
    MW4004280
    Date Received
    January 31, 2007
    Report Date
    January 18, 2007
    Manufacturer
    BIOMEDIX
    Product Code
    JOM
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT WILL SEND E-MAIL WITH SPECIFICS. MULTIPLE PROBLEMS WITH DEVICE. HAS BEEN SENT BACK MULTIPLE TIMES WITHOUT RESOLUTION. LOANER MACHINE DID NOT WORK PROPERLY EITHER. ERRATIC READINGS AND SERIOUS INACCURACIES IN READINGS. EX: MACHINE WILL SAY BLOCKAGE IN LEFT LEG WHEN BLOCKAGE IS ACTUALLY IN RIGHT LEG. LUCKILY EXPERIENCED VASCULAR TECH NOTICED INACCURACIES BEFORE SURGERIES. HAVE HEARD OTHERS IN THE FIELD WITH SAME COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMEDIX PULSE VOLUME RECORDER MODEL VDL JOM BIOMEDIX VDL *

    Patients

    Seq Age Sex Outcome Treatment
    1 *