BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2 INCH AMALGATOME BLADE EXCISION RING 2IN

    MDR report key: 21468612 · Received February 26, 2025

    Report

    Report Number
    MW5166827
    Event Type
    Malfunction
    Date Received
    February 26, 2025
    Date of Event
    February 10, 2025
    Report Date
    February 21, 2025
    Manufacturer
    EXSURCO MEDICAL, INC.
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TWO (2) INCH AMALGATOME BLADE "NOT CUTTING". REFERENCE REPORTS: MW5166828, MW5166829.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026970 2 INCH AMALGATOME BLADE EXCISION RING 2IN DERMATOME GFD EXSURCO MEDICAL, INC. 0108010006780086 261113

    Patients

    Seq Age Sex Outcome Treatment
    1 Female