BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIGAS MONITOR

    MDR report key: 1063127 · Received June 20, 2008

    Report

    Report Number
    2520313-2008-00012
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 20, 2008
    Report Date
    June 20, 2008
    Manufacturer
    MEDRAD, INC.
    Product Code
    CCK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDRAD SALES REPRESENTATIVE WAS PRESENT AT THE SITE DURING THE EVALUATION. THE STAFF DID NOT USE NU-PREP (SKIN-PREP) ON THIS PATIENT PRIOR TO PLACING THE ELECTRODES, DESPITE BEING INSTRUCTED TO DO SO. THE SALES REPRESENTATIVE REPORTED THAT THE LEAD WIRES THAT WERE USED ON THIS PATIENT HAD BEEN USED ON SEVERAL OTHER PATIENTS AT OTHER SITES PRIOR TO THIS EVENT, AND USED ON SEVERAL OTHER PATIENTS ON THE SAME DAY AT THIS SITE WITHOUT ANY PROBLEMS REPORTED. THE PRODUCTS WERE RECENTLY RETURNED FOR EVALUATION. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE SITE WAS EVALUATING THE MONITORING SYSTEM. WHEN THEY REMOVED THE PATIENT FROM THE BORE OF THE MAGNET, THE PATIENT STATED THAT SHE FELT WARM/HOT WHERE THE ELECTRODES WERE PLACED. THE NURSE CHECKED THE SITE WHERE THE ELECTRODES WERE PLACED, AND NO PROBLEMS WERE FOUND. TWO DAYS LATER, THE PATIENT RETURNED TO THE IMAGING CENTER AND SHE HAD A 5MM BLISTER IN THE LEFT UPPER CHEST REGION. A PHYSICIAN LOOKED AT THE PATIENT AND SAID THAT IT WAS A FIRST DEGREE BURN. THE PATIENT WAS GIVEN BACITRACIN OINTMENT TO APPLY OVER THE BLISTER AND WAS CAUTIONED NOT TO BREAK OPEN THE BLISTER. A WEEK LATER, THE PATIENT RETURNED TO THE IMAGING CENTER AND REPORTED THAT THE BURN WAS GETTING WORSE. A PHYSICIAN EXAMINED THE PATIENT AND REPORTED THAT THE BLISTER WAS OPEN AND THERE WAS A SMALL AREA OF SCARRING NOTED. PATIENT WAS GIVEN A PRESCRIPTION FOR KEFLEX 250MG EVERY 8 HOURS FOR THE NEXT 7 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIGAS MONITOR MULTIGAS MONITOR CCK MEDRAD, INC. VERIS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention