BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARAYA 5

    MDR report key: 20289965 · Received September 24, 2024

    Report

    Report Number
    1480288-2024-00001
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    July 24, 2024
    Report Date
    September 24, 2024
    Manufacturer
    SCAPA TAPES NORTH AMERICA LLC
    Product Code
    EXE
    UDI-DI
    00610075079056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER NOT PROVIDED SO DHR REVIEW NOT POSSIBLE. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. POST MARKET SURVEILLANCE DATA REVIEWED, AND NO ADVERSE TRENDS OBSERVED. THE ROOT CAUSE OF THE REPORTED SKIN IRRITATION WHILE USING THE KARAYA POWDER COULD NOT BE IDENTIFIED. CAUSATION COULD NOT BE ESTABLISHED.ONLY GUDID DI INFORMATION IS KNOWN FOR THIS PRODUCT. LOT NUMBER AND PACKAGING NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 WEEKS AGO AN END USER USED OUR KARAYA POWDER, AND IT CAUSED A SKIN RASH AND IRRITATION. IT WAS FURTHER REPORTED THAT THE END USER HAD TO GO TO THE ER AND WAS PRESCRIBED PREDNISONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2104982 KARAYA 5 KARAYA STOMA POWDER EXE SCAPA TAPES NORTH AMERICA LLC 7905 UNKNOWN 00610075079056

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention