BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECOLAB

    MDR report key: 12041123 · Received June 22, 2021

    Report

    Report Number
    3012811961-2021-00004
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    June 8, 2021
    Report Date
    June 22, 2021
    Manufacturer
    MICROTEK MEDICAL INC.
    Product Code
    PUI
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A PROCEDURE, THE WARMING DRAPE WAS LEAKING AND HAD A HOLE IN THE DRAPE. ANTIBIOTICS WERE PRESCRIBED AS A PREVENTATIVE MEASURE. NO ADDITIONAL INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940079 ECOLAB WARMER DRAPE PUI MICROTEK MEDICAL INC. ORS-300 D193449

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention