BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHO® NEXUS SPIRIT® CUSHION

    MDR report key: 6854237 · Received September 11, 2017

    Report

    Report Number
    1419507-2017-00004
    Event Type
    Injury
    Date Received
    September 11, 2017
    Date of Event
    August 10, 2017
    Report Date
    September 8, 2017
    Manufacturer
    ROHO, INC.
    Product Code
    KIC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT DID NOT CLAIM THE DEVICE WAS MALFUNCTIONING. HE ONLY STATED THAT THE CUSHION WAS TOO SMALL AND THAT THIS IS WHAT LED TO THE INJURY. ROHO, INC. MADE SEVERAL ATTEMPTS TO CONTACT THE PATIENT IN ORDER TO OBTAIN ADDITIONAL INFORMATION FOR THIS REPORT, HOWEVER, THE PATIENT DID NOT REPLY. ROHO, INC. HAS NOT SEEN ANY MEDICAL RECORDS AND CAN THEREFORE NOT CONFIRM THE CLAIM OF INJURY.

    Description of Event or Problem · 1

    PATIENT CONTACTED ROHO, INC. BY TELEPHONE STATING HE HAS BREAKDOWN ON HIS BOTTOM. PATIENT ALSO CLAIMS THAT HE IS CONFINED TO HIS BED BECAUSE OF THE BREAKDOWN AND NEEDS A DIFFERENT CUSHION. HE ALSO CONTACTED OUR SALES REP BY TEXT STATING HE HAD AN OPEN PRESSURE SORE ON HIS TAILBONE AND THAT THE SKIN ON HIS BACK AND REAR ARE SCARRED FROM THE NUMEROUS PRESSURE SORES HE HAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635889 ROHO® NEXUS SPIRIT® CUSHION WHEELCHAIR CUSHION KIC ROHO, INC. NS1717C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention