BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROHO PILLOW

    MDR report key: 16973751 · Received May 22, 2023

    Report

    Report Number
    16973751
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    May 3, 2023
    Report Date
    May 8, 2023
    Manufacturer
    ROHO, INC.
    Product Code
    KIC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE INFLATING THE PILLOW, THE ROHO PUMP EXPLODED AND THE PLASTIC TOP BROKE, SENDING THE METAL ROD OUT OF THE TUBE AND LACERATING TWO OF THE FELLOW SURGEON'S FINGERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816476 ROHO PILLOW CUSHION, FLOTATION KIC ROHO, INC. IFU-0015R02

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other