BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEPITEL FILM

    MDR report key: 20842026 · Received December 3, 2024

    Report

    Report Number
    MW5163067
    Event Type
    Other
    Date Received
    December 3, 2024
    Date of Event
    November 4, 2024
    Report Date
    November 25, 2024
    Manufacturer
    MOLNLYCKE HEALTH CARE US, LLC.
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT HAS BEEN DECLINING PHYSICALLY, COGNITIVELY, AND FUNCTIONAL THE LAST 6 MONTHS. PATIENT HAD MULTIPLE HOSPITALIZATION AND ER VISIT DURING THIS TIME PERIOD FOR UTIS, FALLS, SKIN ULCERS, AND PNEUMONIA. PATIENT WAS MOVED TO ASSIST LIVING IN (B)(6) 2024 AND REQUIRED 24/7 ASSISTANCE BY (B)(6) 2024. AFTER HER FINAL ADMISSION ON (B)(6) 2024 FOR FATIGUE, FALL, AND ELEVATED LACTIC ACID, PATIENT DECIDED TO GO ON HOSPICE CARE. PATIENT OFFICIALLY WENT ON HOSPICE (B)(6) 2024. PATIENT DIED (B)(6) 2024. DEATH WAS REPORTED ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050414 MEPITEL FILM DRESSING, WOUND, DRUG FRO MOLNLYCKE HEALTH CARE US, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Hospitalization| D