BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHO HIGH PROFILE SINGLE COMPARTMENT CUSHION

    MDR report key: 16731849 · Received April 13, 2023

    Report

    Report Number
    3008630266-2023-00005
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    March 17, 2023
    Report Date
    April 12, 2023
    Manufacturer
    ROHO, INC.
    Product Code
    KIC
    UDI-DI
    00613732005245
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER CLAIMS THAT HE DEVELOPED A STAGE 4 PRESSURE SORE DUE TO CUSHION GOING FLAT BUT ROHO, INC. HAS NOT SEEN MEDICAL RECORDS TO CONFIRM THIS. THE MANUFACTURING RECORDS WERE REVIEWED AND INDICATED THE CUSHION PASSED ALL INSPECTIONS AND VERIFICATIONS. IT IS UNCLEAR IF PRODUCT MALFUNCTION CAUSED OR CONTRIBUTED TO THE PRESSURE WOUND AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. 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 USER IS HOSPITALIZED DUE TO UNRELATED ILLNESS AND IS UNABLE TO RETURN CUSHION TO ROHO, INC AT THIS TIME. THEREFORE, A PRODUCT EVALUATION COULD NOT BE PERFORMED. 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 DUE TO CUSHION GOING FLAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026474 ROHO HIGH PROFILE SINGLE COMPARTMENT CUSHION WHEELCHAIR CUSHION KIC ROHO, INC. 1R1010C 00613732005245

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other