BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB BLISTER GEL GUARD FOR HEELS / ADV PROTECT BLISTER / HEAL

    MDR report key: 18185087 · Received November 21, 2023

    Report

    Report Number
    2214133-2023-00037
    Event Type
    Injury
    Date Received
    November 21, 2023
    Report Date
    November 7, 2023
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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. A4, A5: PATIENT WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. B3: JUNE 2023. D1, D2, D3, D4: THIS REPORT IS FOR ONE (1) BAND-AID BLISTER GEL GUARD FOR HEELS / ADV PROTECT BLISTER / HEAL UNSPECIFIED USA NOTAPPLICABLE BAADHLUSUNSP BAADHLUSUNSP , LOT NUMBER NI. D4: UDI, UPC, LOT NUMBER AND EXPIRATION DATE ARE NOT AVAILABLE. D9: 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: E040203 ALSO REFERS TO CONSUMER ALLEGED ABOUT ¿NOTICED SOME AREA WHERE THE ADHESIVE FROM BANDAGE STUCK TO SKIN/WENT INTO HER PORES¿ E172003 ALSO REFERS TO CONSUMER ALLEGED ABOUT ¿DERMATITIS SUBSUMED SKIN THAT ARE RED AND OUTLINE OF THE PATCHES ON FACE¿. E2402 REFERS TO CONSUMER INTENTIONAL MISUSE/OFF-LABEL USE OF THE PRODUCT. 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 50 YEAR OLD FEMALE CONSUMER REPORTED ON EVENT ON 07-NOV-2023. THE CONSUMER STATED THAT SHE STARTED USING BAND-AID BLISTER GEL GUARD FOR HEELS TO COVER ACNE ON FACE SINCE 2022 AND THAT SHE WAS PLEASED WITH HOW THEY WORKED. CONSUMER EXPERIENCED SYMPTOMS IN (B)(6) 2023. SHE NOTICED THE OUTLINE OF PATCHES ON HER FACE AND SOME PATCHES WERE RED. CONSUMER REPORTED THAT SHE PUT PATCHES ON HER EYEBROWS AND IN HAIRLINE, AND IT LOOKS LIKE EYEBROWS ARE THINNING. CONSUMER ALSO NOTICED SOME AREAS WHERE THE ADHESIVE FROM BANDAGE STUCK TO HER SKIN AND WENT INTO HER SKIN PORES. CONSUMER VISITED A DERMATOLOGIST AND PHYSICIAN. AS CONSUMER REPORTED, DOCTORS OPINED THAT IT IS DERMATITIS AND PRESCRIBED HER WITH CREAMS, ONE OF THEM TRIAMCINOLONE. CONSUMER STATED THAT SHE DID NOT TELL DOCTORS ABOUT USING BLISTER PATCHES ON THE ACNE AREAS. THE SYMPTOMS DID IMPROVE AFTER THE CONSUMER STOPPED USING THE PRODUCT, BUT THE CONSUMER IS STILL EXPERIENCING SOME SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916941 BAB BLISTER GEL GUARD FOR HEELS / ADV PROTECT BLISTER / HEAL DRESSING, WOUND, OCCLUSIVE NAD JOHNSON & JOHNSON CONSUMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention