BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FONAR INDOMITABLE AKA UPRIGHT¿ MRI

    MDR report key: 15151889 · Received August 2, 2022

    Report

    Report Number
    2432211-2022-00001
    Event Type
    Injury
    Date Received
    August 2, 2022
    Date of Event
    June 17, 2022
    Report Date
    July 22, 2022
    Manufacturer
    FONAR CORPORATION
    Product Code
    LNH
    PMA / PMN Number
    K002490
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME THE PATIENT HAS REFUSED TO PROVIDE THE INFORMATION AS TO DETERMINE THE EXTENT OF HER INJURY, IF WE RECEIVE ADDITIONAL INFORMATION WE WILL UPDATE THE REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022 A PATIENT WHO HAD BEEN SCANNED ON (B)(6) 2022 REPORTED THAT SHE "FEELS BURNT ON HER ARMS, BACK AND EYES". THE PATIENT ALSO STATED THAT THERE WAS NO REDNESS, "JUST FEELS BURNT". THE PATIENT LATER REPORTED THAT SHE WENT TO AN EMERGENCY ROOM AND WAS TOLD THAT SHE HAD TISSUE DAMAGE ON BOTH ARMS. WE REQUESTED A COPY OF THE ER REPORT, BUT THE PATIENT DID NOT WANT TO PROVIDE IT OR ANY ADDITIONAL INFORMATION THAT WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719348 FONAR INDOMITABLE AKA UPRIGHT¿ MRI MAGNETIC RESONANCE IMAGING SCANNER LNH FONAR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Other