BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE DEVILBISS HEALTHCARE

    MDR report key: 19257904 · Received May 7, 2024

    Report

    Report Number
    3014644996-2024-00002
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    April 8, 2024
    Report Date
    May 7, 2024
    Manufacturer
    COM-DA HEALTHCARE CO.,LTD
    Product Code
    ILS
    UDI-DI
    00822383247151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    FROM DRIVE DEVILBISS MDR 2438477-2024-00023: DRIVE DEVILBISS WAS NOTIFIED OF AN INCIDENT INVOLVING A SHOWER CHAIR BY THE END USER'S WIFE WHO STATED THE SHOWER CHAIR SHATTERED WHILE IN USE. THE END USER FELL AND HIT HIS HEAD ON THE BACK OF THE TUB AND FELL ON HIS LEG STUMP CAUSING AN OPEN WOUND THAT REQUIRED ANTIBIOTICS. 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
    400750 DRIVE DEVILBISS HEALTHCARE SHOWER CHAIR ILS COM-DA HEALTHCARE CO.,LTD RTL12505 00822383247151

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention