BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR 24

    MDR report key: 17191593 · Received June 23, 2023

    Report

    Report Number
    3007350713-2023-06191
    Event Type
    Injury
    Date Received
    June 23, 2023
    Date of Event
    April 29, 2023
    Report Date
    June 20, 2023
    Manufacturer
    QUALITY ELECTRODYNAMICS, LLC
    Product Code
    MOS
    UDI-DI
    00814848020423
    PMA / PMN Number
    K183111
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    QUALITY ELECTRODYNAMICS RECEIVED A COMPLAINT FORWARDED FROM SIEMENS THAT A CONTOUR 24 RF COIL CAUSED A PATIENT BURN. THE BURN WAS ON BACKSIDE OF RIGHT WRIST AND WAS A DIME - NICKEL SIZED BLISTER. THE PATIENT WAS WEARING SCRUBS PROVIDED BY THE HOSPITAL AND WAS NOT SEDATED. THE PATIENT DID NOT REQUEST THAT THE SCAN BE STOPPED. THE PATIENT CHOSE NOT TO SEEK ADDITIONAL MEDICAL CARE FOR THE BURN. THE CONTOUR COIL WAS BEING USED BY ITSELF (WITH NO OTHER COILS) AND WAS POSITIONED OVER THE PATIENT'S PELVIC REGION. PER THE TECHNOLOGIST'S MEMORY: 1. THERE WERE NO PADS BETWEEN THE PATIENTS LEGS. 2. THERE WAS PADDING BETWEEN THE COIL AND BORE. 3. IT IS UNKNOWN IF THERE WERE PADS BETWEEN THE PATIENT' HIPS AND ARMS. 4. IT IS UNKNOWN IF THERE WERE PADS BETWEEN THE PATIENT'S HAND AND THE COIL, BUT THE TECHNICIAN STATED THAT THE PATIENT'S HAND WAS NOT CONTACTING THE COIL AT THE BEGINNING OF THE SCAN. IT IS BELIEVED THAT THE PATIENT MAY HAVE INADVERTENTLY SHIFTED HER/THE COIL'S POSITION DURING THE SCAN, WHICH COULD HAVE CAUSED THE HARD HOUSING OF THE COIL TO CONTACT HER WRIST RESULTING IN THE BURN. THE COIL WAS RETURNED TO SIEMENS AND SUBSEQUENTLY TO QUALITY ELECTRODYNAMICS AFTER THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2214301 CONTOUR 24 MRI RF COIL MOS QUALITY ELECTRODYNAMICS, LLC Q7000183 00814848020423

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other