BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHO® QUADTRO SELECT® HIGH PROFILE® CUSHION

    MDR report key: 14565550 · Received June 1, 2022

    Report

    Report Number
    3008630266-2022-00003
    Event Type
    Injury
    Date Received
    June 1, 2022
    Date of Event
    March 1, 2022
    Report Date
    June 1, 2022
    Manufacturer
    ROHO, INC.
    Product Code
    KIC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER STATED HE HAS A PRESSURE INJURY DUE TO CUSHION GOING FLAT IN REAR LEFT QUAD AREA, BUT ROHO, INC. HAS NOT SEEN MEDICAL RECORDS TO CONFIRM THIS. THE CUSHION WAS RETURNED AND THE EVALUATION REPORT IS ATTACHED. NO PROBLEM FOUND DURING EVALUATION THE CUSHION. ISSUE DETERMINED TO BE INCOMPATIBILITY WITH USER'S ANATOMY AND ISOFLO VALVE ON CUSHION. IF ROHO, INC. BECOMES AWARE OF ADDITIONAL, RELEVANT INFORMATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    CUSTOMER CLAIMS THAT LEAK IN REAR LEFT QUAD OF CUSHION RESULTED IN A PRESSURE INJURY. USER DEVELOPED A PRESSURE INJURY IN (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1933850 ROHO® QUADTRO SELECT® HIGH PROFILE® CUSHION WHEELCHAIR CUSHION KIC ROHO, INC. QS99C

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Other