BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB HELLO KITTY USA

    MDR report key: 16610354 · Received March 24, 2023

    Report

    Report Number
    8041154-2023-00006
    Event Type
    Injury
    Date Received
    March 24, 2023
    Date of Event
    March 7, 2023
    Report Date
    March 9, 2023
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    UDI-DI
    381370056164
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    JOHNSON & JOHNSON CONSUMER, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH JOHNSON & JOHNSON CONSUMER, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, JOHNSON & JOHNSON CONSUMER, INC. OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AND ADMISSION THAT THE DEVICE, JOHNSON & JOHNSON CONSUMER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE (1) BAB HELLO KITTY 20S USA 381370056164 8137005616USB, LOT NUMBER 2771B. UDI #: (B)(4). UPC #: 381370056164. EXPIRATION DATE: NA. LOT #: 2771B. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION AND PRODUCT WAS MANUFACTURED PER SPECIFICATION. THE PRODUCT WAS MANUFACTURED ON OCTOBER 4, 2021. HEALTH EFFECT CLINICAL CODE: E1714 ALSO REFER TO CONSUMER ALLEGED ABOUT "REDNESS, SPOTS". E2402 REFERS TO CONSUMER "INTENTIONAL MISUSE/OFF-LABEL USE" OF THE PRODUCT FOR USED FOR CHEST BRUISE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    A FATHER REPORTED AN EVENT ON BEHALF OF HIS DAUGHTER REGARDING BAND AIDE HELLO KITTY BANDAGE. THE CONSUMER HAD RED BLISTERING SPOTS AT THE LOCATION OF BANDAGE AFTER TWO DAYS OF APPLICATION. IT WAS REPORTED THAT, THE BAND-AID WAS USED FOR A CHEST BRUISE AND THE REACTIONS HAVE IMPROVED WHILE REPORTING THIS EVENT. CONSUMER VISITED HEALTH CARE PROFESSIONAL (HCP) AND WAS RECOMMENDED TO USE PRESCRIBED HYDROCORTISONE CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520607 BAB HELLO KITTY USA TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC 381370056164 2771B 381370056164

    Patients

    Seq Age Sex Outcome Treatment
    1 35 MO Female Required Intervention