BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHO QUADTRO SELECT HIGH PROFILE CUSHION

    MDR report key: 11970128 · Received June 9, 2021

    Report

    Report Number
    3008830266-2021-00009
    Event Type
    Injury
    Date Received
    June 9, 2021
    Date of Event
    May 10, 2021
    Report Date
    June 4, 2021
    Manufacturer
    ROHO, INC.
    Product Code
    KIC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDICAL DEVICE PROVIDER CONTACTED ROHO, INC. ON BEHALF OF THE ENDUSER AND STATED THE ENDUSER WAS IN THE HOSPITAL DUE TO PRESSURE SORES. ROHO, INC. HAS NOT SEEN MEDICAL RECORDS SO THE FULL EXTENT OF THE PRESSURE INJURY IS UNKNOWN. THE CUSHION WAS RETURNED TO ROHO, INC. AND WAS FOUND TO HAVE A MANUFACTURING DEFECT IN ONE OF THE CELLS THAT CREATED A SMALL HOLE DURING USE BY THE END USER. ROHO, INC. CONTACTED THE PROVIDER TO OBTAIN CONTACT INFORMATION FOR THE CUSTOMER FOR ADDITIONAL INVESTIGATION. THE CUSTOMER WAS CONTACTED TWICE BY PHONE AND VOICEMAILS WERE LEFT EACH TIME. A LETTER WAS ALSO SENT TO THE CUSTOMER, BUT WE HAVE RECEIVED NO RESPONSE. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PROVIDER CALLED AND STATED THAT THE END USER IS IN THE HOSPITAL BECAUSE OF PRESSURE SORES HE ALLEGEDLY RECEIVED FROM OUR CUSHION. SHE STATED THAT IT HAS A SEAM LEAK. HE ONLY USED THE CUSHION FOR ONE WEEK. HE WAS USING ANOTHER KIND OF CUSHION PRIOR TO OURS. I ASK IF THE SORES COULD OF BEEN FROM THE OTHER CUSHION AND SHE STATED IT WAS A COMBINATION FROM BOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867407 ROHO QUADTRO SELECT HIGH PROFILE CUSHION WHEELCHAIR CUSHION KIC ROHO, INC. QS1111C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other