BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHO MOSAIC CUSHION

    MDR report key: 11286757 · Received February 5, 2021

    Report

    Report Number
    3008630266-2021-00002
    Event Type
    Injury
    Date Received
    February 5, 2021
    Date of Event
    November 17, 2020
    Report Date
    February 4, 2021
    Manufacturer
    ROHO, INC.
    Product Code
    KIC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CALLER STATED THAT HER SON HAD A PRESSURE INJURY, 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. ATTEMPTED TO CONTACT THE CUSTOMER FOR ADDITIONAL INVESTIGATION TWICE BY PHONE, AND SENT A LETTER, WITH NO RESPONSE. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE END USER'S MOTHER CALLED AND STATED THE FOLLOWING: HER SON WAS HOSPITALIZED IN (B)(6) 2020 AND THE HOSPITAL ORDERED HIM A ROHO MOSAIC CUSHION ON (B)(6) 2020. HER SON USED THE CUSHION WHEN HE GOT HOME, BUT SHE NOTICED IT WAS DEFLATED AFTER A COUPLE OF HOURS. SHE WAS ABLE TO PATCH THE CUSHION WITH THE PROVIDED REPAIR KIT. A COUPLE OF DAYS LATER, THE CUSHION WAS DEFLATED AGAIN. SINCE SITTING ON A DIFFERENT CUSHION, HER SON'S PRESSURE SORE HAS GOTTEN WORSE. NURSES CAME TO THEIR HOUSE. THEY MEASURED THE WOUND AND SAID IT HAS GOTTEN 2 INCHES WIDER AND 3 INCHES LONGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184192 ROHO MOSAIC CUSHION WHEELCHAIR CUSHION KIC ROHO, INC. MOS1616CA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other