BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHO® HYBRID SELECT CUSHION

    MDR report key: 15340466 · Received September 1, 2022

    Report

    Report Number
    3008630266-2022-00005
    Event Type
    Injury
    Date Received
    September 1, 2022
    Date of Event
    July 31, 2022
    Report Date
    September 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 ALLEGED THAT A PRESSURE INJURY WORSENED DUE TO CUSHION GOING FLAT, 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 OR CONTRIBUTED TO THE PRESSURE WOUND. 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 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, WE WILL SUBMIT A FOLLOW UP REPORT.

    Description of Event or Problem · 0

    CUSTOMER CLAIMS THAT A BLADDER LEAK IN THE CUSHION CAUSED AN EXISTING PRESSURE SORE TO WORSEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2808714 ROHO® HYBRID SELECT CUSHION WHEELCHAIR CUSHION KIC ROHO, INC. HS1618C

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other