BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK MEDICAL INC.

    MDR report key: 11802434 · Received May 10, 2021

    Report

    Report Number
    8043817-2021-00002
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 26, 2021
    Report Date
    May 10, 2021
    Manufacturer
    MICROTEK MEDICAL INC.
    Product Code
    KKX
    PMA / PMN Number
    K882724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PINHOLES WERE OBSERVED IN THE PROBE COVER FILM ONCE THE ULTRASOUND GEL AND RUBBER BANDS WERE IN PLACE. NO INFECTION OR PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697196 MICROTEK MEDICAL INC. PROBE COVER KKX MICROTEK MEDICAL INC. PC1292 D210191

    Patients

    Seq Age Sex Outcome Treatment
    1