BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHO HIGH PROFILE SINGLE COMPARTMENT CUSHION

    MDR report key: 12624391 · Received October 13, 2021

    Report

    Report Number
    3008630266-2021-00013
    Event Type
    Injury
    Date Received
    October 13, 2021
    Report Date
    October 13, 2021
    Manufacturer
    ROHO, INC.
    Product Code
    KIC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE END USER ALLEGED THAT THE YELLOW ROPE ATTACHED TO THE LEFT FRONT CORNER GROMMET OF THE CUSHION CAUSED A PRESSURE INJURY THAT WILL REQUIRE SURGERY. ROHO, INC. HAS NOT SEEN MEDICAL RECORDS TO CONFIRM THIS. THE CUSHION WAS NOT RETURNED TO ROHO, INC. AS IT WAS CONFIRMED BY THE ATP THAT THE ENDUSER CONTINUED TO USE THE CUSHION BECAUSE IT WAS WORKING CORRECTLY WITH NO MALFUNCTION. THE YELLOW ROPE ATTACHED TO THE CUSHION IS A BRANDING / MARKETING TOOL AND DOES NOT AID IN THE PROPER FUNCTIONING OF THE CUSHION. AN INTERNAL INVESTIGATION WAS CONDUCTED USING THE SAME MODEL NUMBER CUSHION AND FOUND THAT THE YELLOW ROPE COULD ONLY POTENTIALLY COME INTO CONTACT WITH THE 4 CELLS LOCATED IN THE FRONT LEFT CORNER OF THE CUSHION. THE YELLOW ROPE IS INTENDED TO HANG DOWN FROM THE CUSHION AND THE PROBABILITY OF OCCURRENCE OF THE YELLOW ROPE BEING INSIDE THE COVER AND BEING POSITIONED ON ONE OF THOSE 4 CELLS IN ORDER TO CAUSE IS VERY LOW. CURRENTLY, THERE ARE NO OTHER COMPLAINTS REGARDING ALLEGED PRESSURE INJURIES CAUSED BY THE YELLOW ROPE.

    Description of Event or Problem · 0

    END USER CLAIMS THAT THE YELLOW CORD ON HIS ROHO CUSHION WAS INSIDE OF THE CUSHION. BECAUSE HE WAS NOT AWARE OF IT, HE ALLEGES IT CAUSED HIM TO HAVE A SKIN BREAK DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524244 ROHO HIGH PROFILE SINGLE COMPARTMENT CUSHION HIGH PROFILE SINGLE COMPARTMENT CUSHION, WHEELCHAIR CUSHION KIC ROHO, INC. 1R1010C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other