BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMART ROLLBOARD

    MDR report key: 18211704 · Received November 24, 2023

    Report

    Report Number
    MW5148518
    Event Type
    Other
    Date Received
    November 24, 2023
    Report Date
    November 22, 2023
    Manufacturer
    SAMARIT MEDICAL INDUSTRIES INC.
    Product Code
    FMR
    Report Source
    Voluntary report
    Reporter Location
    PL
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (B)(6) WAS INFORMED THAT ON 24 OCTOBER 2023 IN (B)(6) HOSPITAL (B)(6), AN EMPLOYEE INJURED HER NECK AND LEFT ARM WHILE TRANSFERRING THE PATIENT. FOLLOWING INFORMATION REPORTED WHILE THE CAREGIVER WAS "PULLING THE ROLLER BOARD OUT FROM UNDER THE PATIENT, FELT A POP IN LEFT SHOULDER AND NECK AND LEFT ARM. THE ARM AND FINGERS ON THE LEFT SIDE ARE NUMB AND CAREGIVERS CAN'T RAISE THE LEFT ARM". THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524031 SMART ROLLBOARD DEVICE, TRANSFER, PATIENT, MANUAL FMR SAMARIT MEDICAL INDUSTRIES INC. 4100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown