BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALGREENS

    MDR report key: 20836901 · Received December 3, 2024

    Report

    Report Number
    1038758-2024-00030
    Event Type
    Injury
    Date Received
    December 3, 2024
    Date of Event
    October 29, 2024
    Report Date
    December 3, 2024
    Manufacturer
    EUROMED, INC.
    Product Code
    NAD
    UDI-DI
    00311917193533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF 12/03/2024 MANUFACTURER HAS COMPLETED THEIR INVESTIGATION WITH NO ISSUES FOUND. ASO REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS WITH NO ISSUES NOTED. REFER TO SECTION B.6 OF THIS REPORT FOR FURTHER DETAILS. PMS (POST MARKET SURVEILLANCE) HAS BEEN REVIEWED FOR THE PAST TWO YEARS (2022 -2023); NO NEGATIVE TREND WAS IDENTIFIED FOR THE ASSOCIATED PRODUCT.

    Description of Event or Problem · 0

    ON THE INITIAL REPORT DATED (B)(6)2024, THE CONSUMER STATED THAT THE PRODUCT BURNED HER HAND AND LEFT SCARS. ON THE COMPLETED CIR RECEIVED FROM THE CONSUMER ON (B)(6)2024, THE CONSUMER STATED THAT SHE USED THE PRODUCT ON HER HAND, AND WHEN SHE REMOVED IT, HER HAND WAS BURNED. THE CONSUMER SENT THE DOCUMENTS FOR HER DOCTOR'S VISIT ON (B)(6) 2024. THE CONSUMER WAS PRESCRIBED WITH CEPHALEXIN 500MG CAPSULE AND ANTIBIOTIC OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2209247 WALGREENS HYDROCOLLOID GEL BANDAGES ONE SIZE NAD EUROMED, INC. UPC#311917193533 00179637 00311917193533

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Other