BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUATE

    MDR report key: 19806750 · Received July 23, 2024

    Report

    Report Number
    1038758-2024-00016
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    June 25, 2024
    Report Date
    July 23, 2024
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF 07/17/2024, NO RETURNED PRODUCTS WERE PROVIDED. UNUSED RETAINED SAMPLES OF THE SAME LOT AS THE REPORTED WERE SUBMITTED TO THE LAB WITH NO DEFECTS NOTED. IN ADDITION, ASO REVIEWED RECORDS OF SATISFACTORY BIOCOMPATIBILITY TESTS FOR THIS TYPE OF PRODUCT WITH NO ISSUES NOTED. REFER TO SECTION B.6 OF THIS REPORT FOR FURTHER DETAILS.

    Description of Event or Problem · 0

    ON THE INITIAL REPORT RECEIVED BY ASO ON 06/21/2024, THE CONSUMER STATED THAT HER HUSBAND HAD RED BLISTERS AND A RASH DUE TO THE BANDAGES. ON THE COMPLETED CONSUMER INFORMATION REPORT (CIR) RECEIVED ON 06/25/2024, SHE STATES THAT HER HUSBAND HAD TO GO TO THE DERMATOLOGIST. THE CONSUMER REFERENCES TWO LOTS. LOT 00209700 IS AN ASO PRODUCT, AND LOT 231102 IS NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964906 EQUATE FLEXIBLE FABRIC BANDAGES ANTIBACTERIAL ALL ONE SIZE KGX ASO LLC UPC#681131006729 00209700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other