BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDSCHENKER STM

    MDR report key: 11146755 · Received January 11, 2021

    Report

    Report Number
    11146755
    Event Type
    Malfunction
    Date Received
    January 11, 2021
    Date of Event
    January 6, 2021
    Report Date
    January 7, 2021
    Manufacturer
    VECTORNATE USA INC
    Product Code
    JSM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THERE WERE 3 INCIDENCES REPORTED AND 2 WITH THE SAME LOT #. THIS IS ONE OF THREE REPORTS. COVID SWAB APPEARED CONTAMINATED IN IT'S ORIGINAL PACKAGING. THE PRODUCTS WERE DISCOLORED AND DID NOT USE ON PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45556 MEDSCHENKER STM APPLICATOR, ABSORBENT TIPPED, STERILE JSM VECTORNATE USA INC KAG076

    Patients

    Seq Age Sex Outcome Treatment
    1