BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHO HIGH PROFILE SINGLE COMPARTMENT CUSHION

    MDR report key: 16371416 · Received February 14, 2023

    Report

    Report Number
    3008630266-2023-00002
    Event Type
    Injury
    Date Received
    February 14, 2023
    Date of Event
    December 25, 2022
    Report Date
    February 13, 2023
    Manufacturer
    ROHO, INC.
    Product Code
    KIC
    UDI-DI
    00613732005825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 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, WE WILL SUBMIT A FOLLOW UP REPORT.

    Description of Event or Problem · 0

    CUSTOMER CLAIMS EXISTING PRESSURE SORE WORSENED DUE TO CUSHION GOING FLAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721578 ROHO HIGH PROFILE SINGLE COMPARTMENT CUSHION WHEELCHAIR CUSHION KIC ROHO, INC. 1R77C 00613732005825

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization