BEUDAMED
    FDA Adverse Event Injury Summary report: N

    24HR, ORAL SUCTION KIT, CHG, HP, 2HR

    MDR report key: 7651687 · Received June 29, 2018

    Report

    Report Number
    1417592-2018-00063
    Event Type
    Injury
    Date Received
    June 29, 2018
    Date of Event
    May 31, 2018
    Report Date
    June 29, 2018
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    NXZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE SPONGE FELL OF THE TIP OF AN ORAL CARE SWAB AND INTO A PATIENT'S MOUTH. IT WAS NOT IDENTIFIED AT WHAT POINT DURING ORAL CARE THIS INCIDENT OCCURRED. REPORTEDLY, THE SPONGE WAS NOT ABLE TO BE RETRIEVED. AFTER MULTIPLE GOOD-FAITH ATTEMPTS, THE FACILITY REPORTED THAT THEY ARE UNABLE OR UNWILLING TO PROVIDE ADDITIONAL PATIENT, PRODUCT, OR PROCEDURAL INFORMATION RELATED TO THIS INCIDENT. NO IMPACT TO THE PATIENT, THE PATIENT'S STABILITY, THE PATIENT'S PLAN OF CARE, OR TO THE PROCEDURE WAS ORIGINALLY REPORTED. NO SAMPLES WERE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. DUE TO THE REPORTED INCIDENT, AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPONGE FELL OF THE TIP OF AN ORAL CARE SWAB AND INTO A PATIENT'S MOUTH. REPORTEDLY, THE SPONGE WAS NOT ABLE TO BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494950 24HR, ORAL SUCTION KIT, CHG, HP, 2HR NXZ MEDLINE INDUSTRIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other