BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSE SYSTEM VIDEO CAMERA DRAPE

    MDR report key: 15321067 · Received August 29, 2022

    Report

    Report Number
    MW5111774
    Event Type
    Injury
    Date Received
    August 29, 2022
    Date of Event
    June 29, 2022
    Report Date
    August 26, 2022
    Manufacturer
    MICROTEK MEDICAL INC.
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    FOREIGN BODY REMOVAL, APPEARED TO BE A PORTION OF TAPE ASSOCIATED WITH A DRESSING FROM THE NEOPROBE DURING THE "INITIAL WITH" USE OF CAMERA DRAPE. RIGHT BREAST MASS WITH RIGHT NIPPLE RETRACTION AND SUBSEQUENT LEFT BREAST MASS, INFILTRATING LOBULAR CARCINOMA WITH NO EVIDENCE OF METASTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388344 CLOSE SYSTEM VIDEO CAMERA DRAPE DRAPE, SURGICAL KKX MICROTEK MEDICAL INC. D213161

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention