BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KROGER

    MDR report key: 23082695 · Received September 18, 2025

    Report

    Report Number
    1038758-2025-00023
    Event Type
    Injury
    Date Received
    September 18, 2025
    Date of Event
    August 21, 2025
    Report Date
    September 18, 2025
    Manufacturer
    ASO AMERICAS, S. DE R. L. DE C. V.
    Product Code
    KGX
    UDI-DI
    00041260384073
    PMA / PMN Number
    K983368
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF 09/11/2025, RETAINED SAMPLES WERE SUBMITTED TO THE LAB FOR TESTING 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. UDI NOTES: THE EXPIRY DATE IS NOT PRESENT ON DEVICE LABEL.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT RECEIVED BY ASO ON (B)(6) 2025, THE CONSUMER STATES THAT AFTER USING THE BANDAGES, HER DAUGHTER DEVELOPED A SEVERE INFECTION, WHICH HAS CAUSED HER SIGNIFICANT DISTRESS. ON THE COMPLETED CONSUMER INFORMATION REPORT (CIR) RECEIVED ON (B)(6) 2025, THE CONSUMER STATES THAT THE PRODUCT CAUSED HER DAUGHTER TO DEVELOP SKIN ERYTHEMA STREAKING UP THE ARM. CAUSED A BURN, BLISTERING AROUND THE EDGE OF WHERE THE BANDAGE WAS. PER CIR THE CONSUMER WENT TO ST. ALPHONSUS URGENT CARE, WHERE SHE WAS PRESCRIBED AMOXICILLIN-CLAVULANATE 875-125 MG PER TABLET AND TRIAMCINOLONE 0.1 % OINTMENT. THE CONSUMER STATES THAT THE ISSUE WAS WITH THE TAPE AREA AND THAT THE SYMPTOMS DID NOT CORRECT AFTER SHE STOPPED USING THE PRODUCT. SHE WAS LEFT WITH A PERMANENT SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635975 KROGER ADVANCED ANTIBACTERIAL STRONG STRIPS BANDAGES KGX ASO AMERICAS, S. DE R. L. DE C. V. UPC#041260384073 225453 00041260384073

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other