BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMALGATOME SD EXCISION RING BLADE 2"

    MDR report key: 25152357 · Received May 12, 2026

    Report

    Report Number
    MW5188049
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 7, 2026
    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

    PROVIDER WAS UNABLE TO TAKE SKIN USING THE 2INCH AMALGATOME BLADE, THE BLADE HAD TO BE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236128 AMALGATOME SD EXCISION RING BLADE 2" DERMATOME GFD EXSURCO MEDICAL, INC. 0 0810006 78008 6 (10)X0000000000070

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Other