BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHO® CONTOUR SELECT® CUSHION

    MDR report key: 19113438 · Received April 16, 2024

    Report

    Report Number
    3008630266-2024-00002
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    March 6, 2024
    Report Date
    April 15, 2024
    Manufacturer
    ROHO, INC.
    Product Code
    KIC
    UDI-DI
    00613732058517
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER'S WIFE CLAIMS THAT CUSTOMER DEVELOPED A STAGE 2 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. THE CUSHION WAS RETURNED AND A PRODUCT EVALUATION WAS PERFORMED, WHICH IDENTIFIED CUSHION CREASING WITH PROBABLE CAUSE DUE TO IMPROPER PRODUCT MAINTENANCE. 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". IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    CUSTOMER'S WIFE CLAIMS THAT CUSTOMER DEVELOPED A STAGE 2 PRESSURE WOUND DUE TO CUSHION GOING FLAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445761 ROHO® CONTOUR SELECT® CUSHION WHEELCHAIR CUSHION KIC ROHO, INC. CS1010C 00613732058517

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Other