BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMABLADE

    MDR report key: 6823279 · Received August 28, 2017

    Report

    Report Number
    MW5071807
    Event Type
    Malfunction
    Date Received
    August 28, 2017
    Date of Event
    August 9, 2017
    Report Date
    August 24, 2017
    Manufacturer
    ACCUTEC BLADES, INC.
    Product Code
    MDM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN ACCUTEC BLADE, INC. DERMABLADE WAS ABOUT TO BE USED ON A PATIENT, BUT WAS NOTED TO BE RUSTY ON PRE-USE VISUAL INSPECTION. DERMABLADES ON SUPPLY SHELVES WERE INSPECTED, AND FIVE ADDITIONAL PRODUCTS WERE DISCOVERED RUSTY OR OTHERWISE DISCOLORED. LOTS AFFECTED WERE 0117 AND 1516. ALL PRODUCT PACKAGING APPEARED TO BE PROPERLY SEALED AND INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606104 DERMABLADE DISPOSABLE RAZOR BLADE MDM ACCUTEC BLADES, INC. 72-0001 0117
    606105 DERMABLADE DISPOSABLE RAZOR BLADE MDM ACCUTEC BLADES, INC. 1516

    Patients

    Seq Age Sex Outcome Treatment
    1