BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAZ-SP

    MDR report key: 23238514 · Received October 7, 2025

    Report

    Report Number
    3006055387-2025-00001
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    May 22, 2024
    Report Date
    July 22, 2025
    Manufacturer
    RAZ DESIGN INC.
    Product Code
    INN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DIDN'T RECEIVE ANY DETAILED INFORMATION AND ANY PICTURES AS A PROOF. RAZ IS WAITING FOR MORE INFORMATION FOR AN INVESTIGATION. WE DID A GOOD FAITH EFFORT BY SENDING EMAIL TO ENQUIRE MORE DETAILS BUT UNFORTUNATELY DIDN'T RECEIVE ANY FURTHER INFORMATION TO INVESTIGATE. (FILLED SECTION H6 BUT BASED ON ASSUMPTIONS SO THESE CODES I SELECTED COULD BE INCORRECT AS WELL. I WAS UNABLE TO COMPLETE THIS FORM WITHOUT SELECTING THIS CODES SO IN THE FINAL REPORT THESE CODES MAY BE CHANGED).

    Description of Event or Problem · 0

    RAZ HAS BEEN SERVED WITH A LAWSUIT FROM THE COMMONWEALTH OF (B)(6). THERE IS AN ALLEGATION THAT ON (B)(6)2024 END USER WAS SEVERLY CUT BY EXPOSED SHARP METAL EDGE OF THE SHOWER CHAIR MANUFACTURED BY RAZ DESIGN INC. WHICH REQUIRED IMMEDIATE AND EMERGENT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869455 RAZ-SP MOBILE SHOWER COMMODE CHAIR INN RAZ DESIGN INC. RAZ-SP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| H