BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VECTRA GENISYS

    MDR report key: 2494508 · Received March 9, 2012

    Report

    Report Number
    2494508
    Event Type
    Malfunction
    Date Received
    March 9, 2012
    Date of Event
    February 23, 2012
    Report Date
    March 9, 2012
    Manufacturer
    CHATTANOOGA GROUP INC
    Product Code
    IMG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    TAKEN FROM WRITTEN REPORT: "WE STARTED THE UNIT AT THE SAME SETTINGS AS LAST VISIT. AFTER 3 MINUTES, PATIENT REPORTED A STINGING SENSATION. CHECKED CONTACT OF SOUNDHEAD AND SETTINGS. PAUSED TREATMENT AND CHANGED SETTING TO 1:1W/CM2 AND RESUMED. PATIENT REPORTED STINGING SENSATION AGAIN. DISCONTINUED ULTRASOUND AND PAIN STOPPED. APPLIED ICE PACK FOR 15 MINUTES."======================MANUFACTURER RESPONSE FOR ULTRASOUND UNIT, PT, VECTRA GENISYS (PER SITE REPORTER).======================UNIT HAS BEEN RETURNED TO THE VENDOR FOR REPAIR, DEVICE FAILED PERFORMANCE TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTRA GENISYS ULTRASOUND UNIT, PT IMG CHATTANOOGA GROUP INC VECTRA GENISYS *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR