BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRESSING,MEPILEX 4IN X 4IN

    MDR report key: 19174356 · Received April 23, 2024

    Report

    Report Number
    MW5154174
    Event Type
    Injury
    Date Received
    April 23, 2024
    Date of Event
    August 22, 2023
    Report Date
    August 29, 2023
    Manufacturer
    UNKNOWN
    Product Code
    NAC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPORT: (B)(4): LLT CODES: (B)(4): PRURITUS, (B)(4): RASH, (B)(4): PRODUCT QUALITY ISSUE / NARRATIVE: 79 YEAR OLD MALE WITH MEPILEX DRESSING APPLIED AND FOUND TO HAVE WOUND EDGES AND PERI WOUND SKIN IS RED, EROSION WITH COUPLE OF TINY BLISTERS, THE SIZE IS 9.4 CM X 9.5 CM. THE REDNESS IS IN SQUARE SHAPE LIKE MEPILEX BORDER 6X6 SIZE, WHICH WAS THE DRESSING HE USED. ITCHING IN WOUNDED AREA. SLIGHTLY SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146667 DRESSING,MEPILEX 4IN X 4IN DRESSING, WOUND, HYDROPHILIC NAC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Hospitalization