BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHO, INC.

    MDR report key: 22620733 · Received July 25, 2025

    Report

    Report Number
    3008630266-2025-00004
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    June 26, 2025
    Report Date
    July 25, 2025
    Manufacturer
    ROHO, INC.
    Product Code
    KIC
    UDI-DI
    00613732091880
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DISTRIBUTOR WAS PROVIDED A REPLACEMENT CUSHION UNDER WARRANTY AND REQUESTED TO RETURN THE REPORTED CUSHION TO ROHO FOR INVESTIGATION. AS OF THE TIME OF THIS REPORT, THE RETURN CUSHION HAS NOT BEEN RECEIVED BY ROHO. UPDATED INVESTIGATION WILL BE PROVIDED SHOULD THE CUSHION BE RECEIVED FOR EVALUATION. MANUFACTURING RECORDS INDICATE THE CUSHION PASSED ALL INSPECTIONS AND VERIFICATIONS.

    Description of Event or Problem · 0

    ON 6/26/2025, DEALER ABILITY MEDICAL SUPPLY, INC REPORTED A WARRANTY COMPLAINT TO ROHO CUSTOMER EXPERIENCE REPRESENTATIVE THAT THEIR CLIENT (B)(6) HAD A ROHO CUSHION MODEL QSLGMPC. THE REPRESENTATIVE FROM ABILITY MEDICAL SUPPLY STATED THE CLIENTS CUSHION WAS NO LONGER HOLDING AIR IN THE LEFT REAR QUADRANT OF THE CUSHION. THE REPRESENTATIVE STATED THAT HE WAS UNABLE TO IDENTIFY HOW THE CUSHION WAS LOSING AIR. HE STATED THE CLIENT HAD DEVELOPED A PRESSURE SORE ON THEIR BUTTOCK IN THE LOCATION OF THE DEFLATED CUSHION. A WARRANTY REPLACEMENT WAS ENTERED FOR THE DEFECTIVE CUSHION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2632538 ROHO, INC. WHEELCHAIR CUSHION KIC ROHO, INC. QS1112MPC 00613732091880

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Other