BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    ROHO® QUADTRO SELECT® MID PROFILE¿ CUSHION

    MDR report key: 16029135 · Received December 21, 2022

    Report

    Report Number
    3008630266-2022-00006
    Event Type
    Injury
    Date Received
    December 21, 2022
    Date of Event
    November 30, 2022
    Report Date
    February 9, 2023
    Manufacturer
    ROHO, INC.
    Product Code
    KIC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTOR CLAIMED ON BEHALF OF CUSTOMER THAT LEAK IN CUSHION RESULTED IN A PRESSURE INJURY BUT ROHO, INC. HAS NOT SEEN MEDICAL RECORDS TO CONFIRM THIS. THE MANUFACTURING RECORDS WERE REVIEWED AND INDICATES THE CUSHION PASSED ALL INSPECTIONS AND VERIFICATIONS. IT IS UNCLEAR IF PRODUCT MALFUNCTION CAUSED THE PRESSURE INJURY. 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 NOT RETURNED TO ROHO, INC. SO AN EVALUATION COULD NOT BE PERFORMED. ROHO, INC. CONTACTED THE CUSTOMER FOR MORE INFORMATION REGARDING THE ALLEGED FAILURE OF THE CUSHION, BUT THE CUSTOMER HAS NOT RESPONDED. IF NEW INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE CUSHION ASSOCIATED WITH COMPLAINT WAS RETURNED AND AN EVALUATION REPORT IS ATTACHED. THE PROBABLE CAUSE OF BASE HOLE WAS IMPROPER MAINTENANCE. IF NEW INFORMATION IS RECEIVED, ANOTHER FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    DISTRIBUTOR CLAIMED ON BEHALF OF CUSTOMER THAT LEAK IN CUSHION RESULTED IN A PRESSURE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2917631 ROHO® QUADTRO SELECT® MID PROFILE¿ CUSHION WHEELCHAIR CUSHION KIC ROHO, INC. QS911C

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other