BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK

    MDR report key: 18800739 · Received February 28, 2024

    Report

    Report Number
    8043817-2024-00004
    Event Type
    Malfunction
    Date Received
    February 28, 2024
    Date of Event
    January 25, 2024
    Report Date
    February 28, 2024
    Manufacturer
    ECOLAB/MICROTEK INC
    Product Code
    PUI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE PROCEDURE, SURGERY THE NURSE FOUND A A PERFORATION IN THE DRAPE.THE PRODUCT INVOLVED WAS ORS-188231. NO PATIENT INJURY, INFECTION OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445249 MICROTEK WARMER DRAPE WITH SKIRT PUI ECOLAB/MICROTEK INC ORS-188231 D212793

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown