BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOLLISTER - ANCHOR FAST ORAL ET TUBE FASTENER

    MDR report key: 17011046 · Received May 25, 2023

    Report

    Report Number
    MW5117914
    Event Type
    Death
    Date Received
    May 25, 2023
    Date of Event
    March 7, 2023
    Report Date
    May 24, 2023
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT #(B)(6) 98-YEAR-OLD FEMALE W/ PMH OF ANEMIA, DEMENTIA, HYPERTENSION, PVD HYPERKALEMIA, MALNUTRITION PRESENTED FROM LTC ON (B)(6) 2023 FOLLOWING A FALL. PATIENT DEVELOPED ACUTE RESPIRATORY FAILURE WITH A LARGE LEFT SIDED HEMOTHORAX/ PLEURAL EFFUSION AND CHEST TUBE PLACEMENT, ASPIRATION PNEUMONIA, A FIB. PATIENT WAS INTUBATED (8.0- ET TUBE ) ON (B)(6) 2023 DUE TO RESPIRATORY FATIGUE. ANCHOR FAST ORAL ET TUBE FASTENER WAS USED AND SECURED. PER RT DOCUMENTATION, THE HOLDER WAS CHANGED ON (B)(6) 2023 BY THE RT- THERE WERE NO SKIN TEARS NOTED. POLICY IS TO CHANGE WEEKLY, AND THIS IS WITHIN THE TIMEFRAME. ON (B)(6) 2023, THE PATIENT WAS EXTUBATED TO NRM, AND FAMILY OPTED FOR COMFORT CARE MEASURES. PATIENT EXPIRED AS A DNR ON (B)(6) 2023. IT WAS NOTED (B)(6)2023 THAT AT TIME OF ET REMOVAL PATIENT HAD 2 SKIN TEARS ON RIGHT AND LEFT CHEEKS WHERE THE ADHESIVE ON THE SIDES OF THE ET HOLDER WERE PRESENT . BOTH SKIN TEARS WERE DOCUMENTED AS ONE ABRASION ON (B)(6) 2023 IN THE MR WITH ONE PHOTO NOTED. THERE WAS NO DOCUMENTATION OF THE SKIN TEARS AT TIME OF EXTUBATION/ NO PICTURES TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650213 HOLLISTER - ANCHOR FAST ORAL ET TUBE FASTENER DEVICE, FIXATION, TRACHEAL TUBE CBH HOLLISTER INCORPORATED 9799

    Patients

    Seq Age Sex Outcome Treatment
    1 98 YR Female Other| D