BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUR-CLENS

    MDR report key: 50463 · Received November 12, 1996

    Report

    Report Number
    50463
    Event Type
    Malfunction
    Date Received
    November 12, 1996
    Date of Event
    August 24, 1996
    Report Date
    October 3, 1996
    Manufacturer
    CALGON VESTAL LAB.
    Product Code
    MDZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY THERAPIST LAVAGED PT'S TRACHEOSTOMY TUBE WITH 20CC AMPULE OF SOLUTION THERAPIST THOUGHT WAS USING SALINE, BUT IT WAS A SOAP SOLUTION. PHYSICIAN WAS INFORMED AND PT LAVAGED AND SUCTIONED NUMEROUS TIMES IMMEDIATELY AFTERWARD TO CLEAR AIRWAY. ONLY ABOUT 5CC OF SOLUTION HAD BEEN USED. THE SOAP SOLUTION, IS IN A CLEAR VIAL MARKED "NOT FOR INJECTION", BUT IS NOT IDENTIFIED AS A SOAP SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHUR-CLENS AMPULE OF SOAP SOLUTION MDZ CALGON VESTAL LAB. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR