BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHO® HIGH PROFILE® SINGLE COMPARTMENT CUSHION

    MDR report key: 14521188 · Received May 27, 2022

    Report

    Report Number
    3008630266-2022-00002
    Event Type
    Injury
    Date Received
    May 27, 2022
    Date of Event
    April 14, 2022
    Report Date
    May 27, 2022
    Manufacturer
    ROHO, INC.
    Product Code
    KIC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER STATED HE HAS A PRESSURE INJURY DUE TO CUSHION GOING FLAT, 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, CONTACTED THE CUSTOMER FOR MORE INFORMATION REGARDING THE ALLEGED FAILURE OF THE CUSHION, BUT THE CUSTOMER FAILED TO RESPOND.

    Description of Event or Problem · 0

    CUSTOMER CLAIMS THAT LEAK IN CUSHION RESULTED IN A PRESSURE INJURY. CUSTOMER SAYS HE WENT TO THE DOCTOR BUT WAS NOT HOSPITALIZED. CUSTOMER CLAIMED HE DISCOVERED INJURY ON (B)(6) 2022 AND WAS TREATED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2753325 ROHO® HIGH PROFILE® SINGLE COMPARTMENT CUSHION WHEELCHAIR CUSHION KIC ROHO, INC. 1R1210C

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| O