BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHO® QUADTRO SELECT® HIGH PROFILE® CUSHION

    MDR report key: 20351792 · Received October 2, 2024

    Report

    Report Number
    3008630266-2024-00006
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    September 1, 2024
    Report Date
    October 2, 2024
    Manufacturer
    ROHO, INC.
    Product Code
    KIC
    UDI-DI
    00613732054328
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER CLAIMS THAT HE DEVELOPED A STAGE 4 PRESSURE SORE REQUIRING SURGERY DUE TO CUSHION GOING FLAT. HOWEVER, ROHO, INC. HAS NOT SEEN MEDICAL RECORDS TO CONFIRM THIS. THE MANUFACTURING RECORDS WERE REVIEWED AND INDICATED THE CUSHION PASSED ALL INSPECTIONS AND VERIFICATIONS. THE USER HAS WARNING IN THE MANUAL TO DISCONTINUE USE OF A DEFECTIVE PRODUCT THAT READS AS FOLLOWS: "CHECK SKIN FREQUENTLY, AT LEAST ONCE A DAY. REDNESS, BRUISING, OR DARKER AREAS (WHEN COMPARED TO NORMAL SKIN) MAY INDICATE SUPERFICIAL OR DEEP TISSUE INJURY AND SHOULD BE ADDRESSED. IF THERE IS ANY DISCOLORATION TO SKIN/SOFT TISSUE, STOP USE IMMEDIATELY. IF THE DISCOLORATION DOES NOT DISAPPEAR WITHIN 30 MINUTES AFTER DISUSE, IMMEDIATELY CONSULT A HEALTHCARE PROFESSIONAL. - CHECK INFLATION FREQUENTLY, AT LEAST ONCE A DAY. - DO NOT USE A PRODUCT THAT IS UNDERINFLATED OR OVERINFLATED, BECAUSE 1) THE PRODUCT BENEFITS WILL BE REDUCED OR ELIMINATED, RESULTING IN AN INCREASED RISK TO SKIN AND OTHER SOFT TISSUE.". THE CUSHION WAS RETURNED AND AN EVALUATION REPORT IS ATTACHED. EVALUATION OF THE CUSHION REVEALED A LACERATION LIKELY CAUSED BY EXCESSIVE EXTERNAL FORCE APPLIED TO CUSHION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    CUSTOMER CLAIMS THAT HE DEVELOPED A PRESSURE WOUND REQUIRING SURGERY DUE TO CUSHION GOING FLAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2007337 ROHO® QUADTRO SELECT® HIGH PROFILE® CUSHION WHEELCHAIR CUSHION KIC ROHO, INC. QS1011C 00613732054328

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Hospitalization