BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CHECK¿ BY ROHO®

    MDR report key: 9419201 · Received December 5, 2019

    Report

    Report Number
    1419507-2019-00008
    Event Type
    Injury
    Date Received
    December 5, 2019
    Date of Event
    November 5, 2019
    Report Date
    December 4, 2019
    Manufacturer
    ROHO, INC.
    Product Code
    JFC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ADVISES THAT THEY ARE CURRENTLY SEEING A WOUND CARE SPECIALIST FOR THEIR ALLEGED INJURY. THE CUSTOMER'S CONDITION IS IN THE PROCESS OF HEALING AND HAS NOT BEEN REPORTED AS WORSENING. BOTH THE SMART CHECK DEVICE AND THE CONCOMITANT CUSHION WERE RETURNED AND EVALUATED BY THE EXAMINING QUALITY ENGINEER. NO MANUFACTURING DEFECTS WERE FOUND WITH EITHER PRODUCT AND ALL TEST FOR FUNCTIONALITY WERE PASSED. THE CUSTOMER STATES THAT THEY ATTEMPTED TO UTILIZE THE DEVICE ACCORDING TO SPECIFICATIONS, BUT IT IS A PRODUCT THAT IS UNFAMILIAR TO THEM WHICH MAY HAVE CONTRIBUTED TO THE ERROR. ALTHOUGH AN ALLEGED INJURY HAS BEEN REPORTED, NO MEDICAL RECORDS HAVE BEEN SUBMITTED FOR CONFIRMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PER CUSTOMER REPORT, "THIS ROHO SMART CHECK HAS TURNED A SMALL PRESSURE SORE TO A REAL PROBLEM. I CHECKED THE GAUGE DAILY, AND IT ALWAYS READ "GREEN" (WHICH IS OK), HOWEVER AT SOME POINT, I BOTTOMED OUT ON MY WHEELCHAIRS HARD SEAT BASE, EVEN THOUGH IT STILL READ "GREEN". I DID DO A PHYSICAL CLEARANCE TEST TO ENSURE I WAS NOT BOTTOMED OUT WHEN I FIRST BEGAN USING THIS CUSHION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214379 SMART CHECK¿ BY ROHO® SMART CHECK DEVICE JFC ROHO, INC. SMARTCHECK-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other