BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHO MOSAIC CUSHION

    MDR report key: 12355556 · Received August 23, 2021

    Report

    Report Number
    3008630266-2021-00011
    Event Type
    Injury
    Date Received
    August 23, 2021
    Report Date
    August 23, 2021
    Manufacturer
    ROHO, INC.
    Product Code
    KIC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENDUSER STATED THAT HE HAD AN EXISTING PRESSURE INJURY THAT WORSENED DUE TO THE PERFORMANCE OF THE CUSHION, BUT ROHO, INC. HAS NOT SEEN MEDICAL RECORDS TO CONFIRM THIS. 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 WAS NOT WILLING TO PROVIDE FURTHER DETAILS.

    Description of Event or Problem · 1

    MR (B)(6) CLAIMS THAT DUE TO THE LACK OF PERFORMANCE OF OUR PRODUCT HE HAS SORES TO WHERE HE CAN ONLY STAND. HE WAS UNSURE OF THE EXACT DATE OF ALLEGED INJURY, CLAIMS THAT HE HAS BEEN DEALING WITH THE ISSUE FOR SEVERAL WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252444 ROHO MOSAIC CUSHION WHEELCHAIR CUSHION KIC ROHO, INC. MOS2018CA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other