BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDSOURCE AND CURAPLEX

    MDR report key: 23180820 · Received September 30, 2025

    Report

    Report Number
    3009512503-2025-00214
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Report Date
    September 30, 2025
    Product Code
    FPY
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    STERILE BURN SHEET PACKAGING WAS OBSERVED TO BE OPEN AT THE BOTTOM OF THE PACKAGING. MULTIPLE LOTS AND PART NUMBERS ARE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586988 MEDSOURCE AND CURAPLEX BURN SHEET FPY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown