BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRACO

    MDR report key: 8554494 · Received April 26, 2019

    Report

    Report Number
    8554494
    Event Type
    Malfunction
    Date Received
    April 26, 2019
    Date of Event
    April 16, 2019
    Report Date
    April 17, 2019
    Manufacturer
    CYGNUS MEDICAL, LLC
    Product Code
    FRL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DEEP CLEANING PADS WERE FOUND WITH MOLD INSIDE SEALED PACKAGE. EXPIRATION DATE: 12/31/2020. BOX WAS THROWN AWAY SO WE ARE UNSURE OF THE LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349349 DRACO ACCESSORIES, CLEANING, PAD FRL CYGNUS MEDICAL, LLC HY0305Z

    Patients

    Seq Age Sex Outcome Treatment
    1