BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSYSTEM STERILE TRANSPORT SWAB

    MDR report key: 9818401 · Received March 11, 2020

    Report

    Report Number
    9818401
    Event Type
    Malfunction
    Date Received
    March 11, 2020
    Date of Event
    February 2, 2020
    Report Date
    February 14, 2020
    Manufacturer
    COPAN DIAGNOSTICS, INC.
    Product Code
    JSM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    STERILE SWABSTICK NOTED TO BE DEFECTIVE WITH ONE SWAB IN PACKAGE. THIS WAS IN 2 DIFFERENT PACKAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280723 TRANSYSTEM STERILE TRANSPORT SWAB CULTURE MEDIA, NON-PROPAGATING TRANSPORT JSM COPAN DIAGNOSTICS, INC. 900-0370 191199200

    Patients

    Seq Age Sex Outcome Treatment
    1