BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAROEX

    MDR report key: 10894207 · Received November 24, 2020

    Report

    Report Number
    10894207
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    August 10, 2020
    Report Date
    November 6, 2020
    Manufacturer
    SUNSTAR AMERICAS
    Product Code
    NTO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 10/28/2020 THE FDA SENT OUT A RECALL FOR SUNSTAR CHLORHEXIDINE GLUCONATE ORAL RINSE DUE TO BACTERIA BURKHOLDERIA LATA. THIS PRODUCT WAS USED AT THE HOSPITAL BETWEEN JULY AND OCTOBER 2020. THERE ARE 11 PATIENTS WHO HAD POSITIVE CULTURES FOR BACTERIA BURKHOLDERIA CEPACIA. EACH OF THE PATIENTS INVOLVED HAD THOROUGH INVESTIGATIONS. PATIENTS WERE TREATED AS APPROPRIATE BY THEIR PHYSICIANS. THE POSITIVE CULTURES WERE REPORTED THROUGH (B)(6) AS WARRANTED AS WELL AS TO THE LOCAL DEPARTMENT OF HEALTH. FDA HAS ALSO BEEN ALERTED. APPROPRIATE PATIENT NOTIFICATION HAS BEEN ACCOMPLISHED. ALL AFFECTED INVENTORY HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361603 PAROEX CHLORHEXIDINE GLUCONATE NTO SUNSTAR AMERICAS

    Patients

    Seq Age Sex Outcome Treatment
    1