BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND HYDROSEAL BANDAGES ALL PURPOSE

    MDR report key: 17712557 · Received September 8, 2023

    Report

    Report Number
    2214133-2023-00027
    Event Type
    Injury
    Date Received
    September 8, 2023
    Report Date
    August 18, 2023
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. D1, D2, D3, D4: THIS REPORT IS FOR ONE (1) BAND AID BRAND HYDROSEAL BANDAGES ALL PURPOSE UNSPECIFIED USA NOTAPPLICABLE BAHYBAUSUNSP BAHYBAUSUNSP, LOT NUMBER N/A. D4: UPC #, LOT #, EXPIRATION DATE AND UDI # ARE NOT AVAILABLE. D10: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. H6: HEALTH EFFECT CLINICAL CODE: E2402 REFERS TO CONSUMER "INTENTIONAL MISUSE/OFF-LABEL USE" OF THE PRODUCT. E040203 ALSO REFERS TO CONSUMER ALLEGED ABOUT "FEEL LIKE LEFT EAR PROBABLY GOT DAMAGED. 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 FEMALE CONSUMER REPORTED AN EVENT WITH ALL PURPOSE BAND AID BRAND HYDROSEAL BANDAGE. SHE HAD BEEN USING PRODUCT ON HER SKIN FOR 2 MONTHS AND COULD NOT REMOVE FROM HER FACE. CONSUMER WAS USING THE PRODUCT FOR WOUNDS ON HER EAR AND LEG. BANDAGE WAS PLACED BELOW EAR, DOWN JAWLINE. CONSUMER STATED THAT THE WOUND STARTED TO GET INFECTED. WHEN TRYING TO REMOVE PRODUCT, SHE THOUGHT IT RIPPED HER SKIN OFF BUT THE PRODUCT WAS STUCK ON HER. SHE ALLEGED THAT HER LEFT EAR PROBABLY GOT DAMAGED. CONSUMER WAS HAVING INFECTIONS DUE TO THE PRODUCT. THEREFORE, CONSUMER SOUGHT ATTENTION FROM HEALTH CARE PROFESSIONAL (HCP) AND THE HCP PRESCRIBED AN UNKNOWN ¿HEAVY DUTY¿ ANTIBIOTIC FOR THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614657 BAND AID BRAND HYDROSEAL BANDAGES ALL PURPOSE DRESSING, WOUND, OCCLUSIVE NAD JOHNSON & JOHNSON CONSUMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention