BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESWICK PUNCH

    MDR report key: 565708 · Received December 29, 2004

    Report

    Report Number
    MW1034181
    Event Type
    Malfunction
    Date Received
    December 29, 2004
    Report Date
    December 29, 2004
    Manufacturer
    SKLAR INSTRUMENTS
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PUNCH LEAVES A GRAY RING, WHICH CAUSES CONCERN REGARDING FUTURE COSMETIC RESULT. ALSO, IN ONE PT, MARKED SKIN REDNESS AND SWELLING WAS NOTED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESWICK PUNCH BIOPSY PUNCH KNW SKLAR INSTRUMENTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *