BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHO® QUADTRO SELECT® LOW PROFILE® CUSHION

    MDR report key: 14497906 · Received May 25, 2022

    Report

    Report Number
    3008630266-2022-00001
    Event Type
    Injury
    Date Received
    May 25, 2022
    Date of Event
    December 1, 2022
    Report Date
    May 25, 2022
    Manufacturer
    ROHO, INC
    Product Code
    KIC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER STATED HE HAS A PRESSURE INJURY DUE TO CUSHION GOING FLAT, BUT ROHO, INC. HAS NOT SEEN MEDICAL RECORDS TO CONFIRM THIS.THE CUSHION WAS RETURNED AND THE EVALUATION REPORT IS ATTACHED. DAMAGE IS CONSISTENT WITH CUSHION NOT BEING USED AS INSTRUCTED. IF ROHO, INC. BECOMES AWARE OF ADDITIONAL, RELEVANT INFORMATION, A FOLLOW UP REPORT WILL BE SUBMITTED. CUSHION OPERATION MANUAL CONTAINS SAFETY INFORMATION RELATED TO CHECKING SKIN FREQUENTLY FOR REDNESS OR BRUISING AND INSTRUCTIONS FOR DETERMINING IF CUSHION WAS SET UP PROPERLY.

    Description of Event or Problem · 0

    CUSTOMER STATED HE HAD AN ISSUE WITH THE CUSHION GOING FLAT. HE HAS NO FEELING IN THE LOWER PART OF HIS BODY, SO HE DID NOT NOTICE THE CUSHION HAD GONE FLAT UNTIL THE END OF THE DAY. HE CLAIMS THIS DIRECTLY CAUSED A PRESSURE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260970 ROHO® QUADTRO SELECT® LOW PROFILE® CUSHION WHEELCHAIR CUSHION KIC ROHO, INC RQS1010LP

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other BOUNDER POWER WHEELCHAIR