BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOPCARE

    MDR report key: 9119388 · Received September 25, 2019

    Report

    Report Number
    1038758-2019-00040
    Event Type
    Injury
    Date Received
    September 25, 2019
    Report Date
    January 23, 2020
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF 09/23/2019 ASO REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS. ASO HAVEN'T RECEIVED RESPONSE, RETURNED PRODUCT OR LOT NUMBER OF THE REFERRED PRODUCT. REFER TO SECTION B.6 OF THIS REPORT FOR FURTHER DETAILS. ON (B)(6) 2020 TESTING RESULTS ON RETAINED SAMPLES WERE SATISFACTORY WITH NO DEFECTS NOTED. REFER TO SECTION B.6 OF THIS REPORT FOR FURTHER DETAILS. THE FOLLOWING SECTIONS WERE UPDATED: B.6, D4, H.6 (CODES REMOVED: 3221 AND 11. CODES ADDED: 2993, 213, 11 AND 67).

    Description of Event or Problem · 0

    ON THE INITIAL REPORT ON (B)(6) 2019 CONSUMER REPORTED HAD A REACTION TO THE ADHESIVE PART OF THE PRODUCT. CONSUMER ADDED THAT 3 MONTHS LATER SHE STILL HAS A MARK WITH THE SHAPE OF ONE SIDE OF THE BANDAGE ON HER ARM.

    Additional Manufacturer Narrative · 1

    AS OF (B)(6) 2019 ASO REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS. ASO HAVEN'T RECEIVED RESPONSE, RETURNED PRODUCT OR LOT NUMBER OF THE REFERRED PRODUCT.

    Description of Event or Problem · 1

    ON THE INITIAL REPORT ON (B)(6) 2019 CONSUMER REPORTED HAD A REACTION TO THE ADHESIVE PART OF THE PRODUCT. CONSUMER ADDED THAT 3 MONTHS LATER SHE STILL HAS A MARK WITH THE SHAPE OF ONE SIDE OF THE BANDAGE ON HER ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912355 TOPCARE STRONG-STRIPS ADHESIVE BANDAGES ANTIBACTERIAL KGX ASO LLC UPC#036800403031 00085675

    Patients

    Seq Age Sex Outcome Treatment
    1 Other