BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE DEVILBISS HEALTHCARE

    MDR report key: 19527056 · Received June 13, 2024

    Report

    Report Number
    3014644996-2024-00010
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    May 9, 2024
    Report Date
    June 13, 2024
    Manufacturer
    COM-DA HEALTHCARE CO.,LTD
    Product Code
    ILS
    UDI-DI
    00822383247151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    PER MDR #2438477-2024-00030: DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BATH SEAT BY A PROVIDER, WHO REPORTED THE END USER WAS USING THE BATH SEAT WHEN THE CHAIR COLLAPSED. THE NATURE OF THE COLLAPSE HAS NOT BEEN SPECIFIED TO DATE. THE END USER WAS REPORTEDLY ADMITTED TO THE HOSPITAL WITH INJURIES CAUSED BY THE INCIDENT, HOWEVER, THE INJURIES HAVE NOT BEEN SPECIFIED TO DATE. DRIVE ATTEMPTED TO CONTACT THE PROVIDER ON SEVERAL OCCASIONS REGARDING THE INCIDENT AND THE PRODUCT, HOWEVER DID NOT RECEIVE ANY FURTHER INFORMATION. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955215 DRIVE DEVILBISS HEALTHCARE BATH SEAT ILS COM-DA HEALTHCARE CO.,LTD RTL12505 00822383247151

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization