BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEAK BLADE

    MDR report key: 2571154 · Received May 8, 2012

    Report

    Report Number
    MW5025331
    Event Type
    Injury
    Date Received
    May 8, 2012
    Date of Event
    April 25, 2012
    Report Date
    May 2, 2012
    Manufacturer
    PEAK SURGICAL, INC.
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TEFLON COATING CAME OFF THE TIP OF BLADE WHEN IT WAS SCRAPED ON HOLDER TO CLEAN AFTER USING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEAK BLADE BLADE HWE PEAK SURGICAL, INC. 53789

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention