BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECOLAB/MICROTEK MEDICAL INC

    MDR report key: 11801843 · Received May 10, 2021

    Report

    Report Number
    3012811961-2021-00003
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 15, 2021
    Report Date
    May 10, 2021
    Manufacturer
    MICROTEK MEDICAL INC.
    Product Code
    PUI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PINHOLES WERE OBSERVED IN THE DRAPE LEADING TO A CONTAMINATED FIELD. NO INFECTION OR PATIENT HARM WAS REPORTED AS A RESULT OF THE CONTAMINATED FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695846 ECOLAB/MICROTEK MEDICAL INC WARMER DRAPE PUI MICROTEK MEDICAL INC. ORS-100 D203019, D203189, D203179

    Patients

    Seq Age Sex Outcome Treatment
    1