BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHO QUADTRO SELECT HIGH PROFILE CUSHION

    MDR report key: 11457242 · Received March 10, 2021

    Report

    Report Number
    3008630266-2021-00004
    Event Type
    Injury
    Date Received
    March 10, 2021
    Date of Event
    February 10, 2021
    Report Date
    March 11, 2021
    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 CALLER STATED THAT THE END USER HAS A PRESSURE INJURY, BUT ROHO, INC. HAS NO INFORMATION AVAILABLE TO MAKE A DETERMINATION OF THE EXTENT OF THE ALLEGED INJURY. THE CUSHION WAS NOT RETURNED TO ROHO, INC., SO AN EVALUATION COULD NOT BE PERFORMED. ROHO, INC. ATTEMPTED TO CONTACT THE CUSTOMER FOR ADDITIONAL INVESTIGATION TWICE BY PHONE, BUT THEY DID NOT ANSWER AND THERE WAS NO VOICEMAIL SETUP. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CALL WAS RECEIVED STATING A REPLACEMENT CUSHION WAS NEEDED BECAUSE THE CUSHION INFLATION VALVES POPPED OUT OF THE CUSHION. THE CALLER STATED THAT THE END USER HAD A WOUND DUE TO NOT BEING ABLE TO USE THE CUSHION. AFTER CONTACTING THE END USER'S MOTHER, SHE STATED THAT HE HAD USED THE CUSHION SEVERAL TIMES BEFORE THE INFLATION VALVE POPPED OUT. HIS MOTHER STATED HIS PRESSURE INJUY WAS REQUIRING A WOUND VAC FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353673 ROHO QUADTRO SELECT HIGH PROFILE CUSHION WHEELCHAIR CUSHION KIC ROHO, INC. QS1011C

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other