BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHO HYBRID ELITE DUAL COMPARTMENT CUSHION

    MDR report key: 12093603 · Received June 30, 2021

    Report

    Report Number
    3008830266-2021-00010
    Event Type
    Injury
    Date Received
    June 30, 2021
    Report Date
    June 3, 2021
    Manufacturer
    ROHO, INC.
    Product Code
    KIC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED INFORMATION ON 2 CUSHIONS OF THE SAME ITEM NUMBER, BUT COULD NOT PROVIDE FULL DETAILS OF THE TYPE OF FAILURE THAT OCCURRED PER CUSHION OR WHICH CUSHION HE WAS USING WHEN THE PRESSURE INJURY WORSENED. ROHO, INC. HAS NOT SEEN MEDICAL RECORDS TO CONFIRM THE STATUS OF THE CUSTOMER'S PRESSURE INJURY. THE CUSHIONS HAVE NOT BEEN RETURNED TO ROHO, INC, SO AN EVALUATION CANNOT BE PERFORMED. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSHION WAS LOSING AIR AND NOT STAYING INFLATED. THE CUSTOMER STATED HE HAD AN EXISTING PRESSURE INJURY THAT GOT WORSE DUE TO THE ALLEGED FAILURE OF THE CUSHION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989866 ROHO HYBRID ELITE DUAL COMPARTMENT CUSHION WHEELCHAIR CUSHION KIC ROHO, INC. 2RHE1820C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other