BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALGREENS

    MDR report key: 5480941 · Received March 4, 2016

    Report

    Report Number
    1038758-2016-00029
    Event Type
    Injury
    Date Received
    March 4, 2016
    Date of Event
    February 3, 2016
    Report Date
    February 4, 2016
    Manufacturer
    EUROMED, INC.
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF 3/4/2016 ASO HAS NOT RECEIVED RETURNED SAMPLES FROM CONSUMER OR A LOT NUMBER. ASO COMMUNICATED TO THE MANUFACTURER ABOUT THE COMPLAINT ON 3/2/2016 FOR FURTHER INVESTIGATION. IN ADDITION, ASO REVIEWED RECORDS OF BIOCOMPATIBILITY TEST DATA AND THE LABELING FOR THE PRODUCT. PLEASE REFER TO SECTION OF THIS REPORT FOR FURTHER DETAILS.

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT SHE HAD A BURN ON HER WRIST AND USED A HYDROCOLLOID BANDAGE ON IT. CONSUMER REPORTED THAT IT RIPPED THE ENTIRE TOP LAYER OF SKIN OFF. IN ADDITION, SHE REPORTED SHE MAY HAVE A SCAR DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136008 WALGREENS WALGREENS ADVANCE HEALING LARGE PREMIUM BANDAGES - HYDROCOLLOID NAD EUROMED, INC. UPC311917143378

    Patients

    Seq Age Sex Outcome Treatment
    1