BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOPCARE

    MDR report key: 9433175 · Received December 6, 2019

    Report

    Report Number
    1038758-2019-00056
    Event Type
    Injury
    Date Received
    December 6, 2019
    Report Date
    November 6, 2019
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF 12/05/2019 RETURNED PRODUCT AND RETAINED SAMPLES WERE SUBMITTED TO THE LAB FOR TESTING WITH NO DEFECTS NOTED. IN ADDITION, ASO REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS.

    Description of Event or Problem · 1

    ON THE INITIAL REPORT ON (B)(6) 2019 CONSUMER REPORTED THE BANDAGES CAUSED ALLERGIC REACTION TO HER SON. ON (B)(6) 2019 CONSUMER STATED ON RETURNED CIR THAT SHE SOUGHT MEDICAL ATTENTION FOR HER SON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223639 TOPCARE FABRIC ADHESIVE BANDAGES ANTIBACTERIAL KGX ASO LLC UPC#036800403000 00073924

    Patients

    Seq Age Sex Outcome Treatment
    1 Other