BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUTROGENA STUBBORN ACNE ULTRA THIN BLEMISH PATCH

    MDR report key: 18162136 · Received November 17, 2023

    Report

    Report Number
    2214133-2023-00035
    Event Type
    Injury
    Date Received
    November 17, 2023
    Date of Event
    October 28, 2023
    Report Date
    November 1, 2023
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    NAD
    UDI-DI
    070501064368
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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. D1, D2, D3, D4: THIS REPORT IS FOR ONE (1) NEUTROGENA STUBBORN ACNE ULTRA THIN BLEMISH PATCH DOTS 24CT USA 070501064368 070501064368USA 070501064368USA, LOT NUMBER NI. D4: UDI #(B)(4). UPC #070501064368. EXPIRATION DATE: NA. LOT #NI. D9: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. D10: OTHER CONCOMITANT PRODUCTS (NON-DEVICE) USED: NEUTROGENA HYDRO BOOST HYDRATING GEL CLEANSER FRAGRANCE FREE 7.8OZ DOSAGE: APPROX PEA SIZED AMOUNT. PRODUCT START DATE: (B)(6) 2023. LAST USE DATE: (B)(6) 2023. NEUTROGENA HYDRO BOOST WATER GEL 1.7OZ. DOSAGE: APPROX PEA SIZED AMOUNT. PRODUCT START DATE: (B)(6) 2023. LAST USE DATE: (B)(6) 2023. NEUTROGENA CLEAR FACE BREAKOUT FREE OIL FREE SUNSCREEN BROAD SPECTRUM SPF50 3OZ. DOSAGE: APPROX PEA SIZED AMOUNT. PRODUCT START DATE: (B)(6) 2023. LAST USE DATE: (B)(6) 2023. NEUTROGENA HEALTHY SKIN LIQUID MAKEUP SPF20 1OZ CLASSIC IVORY 10. PRODUCT START DATE: (B)(6) 2023. LAST USE DATE: (B)(6) 2023. NEUTROGENA CLEAR COMPLEXION ANTIOXIDANT GUMMY WITH ZINC STRAWBERRY 60CT. DOSAGE: 1 PC. PRODUCT START DATE: (B)(6) 2023. LAST USE DATE: (B)(6) 2023. NEUTROGENA STUBBORN MARKS PM TREATMENT 1OZ. DOSAGE: APPROX PEA SIZED AMOUNT. PRODUCT START DATE: (B)(6) 2023. LAST USE DATE: (B)(6) 2023. NEUTROGENA STUBBORN ACNE AM TREATMENT 2OZ. DOSAGE: APPROX PEA SIZED AMOUNT. PRODUCT START DATE: (B)(6) 2023. LAST USE DATE: (B)(6) 2023. NEUTROGENA STUBBORN TEXTURE DAILY CLEANSER 6.3OZ. DOSAGE: APPROX PEA SIZED AMOUNT. PRODUCT START DATE: (B)(6) 2023. LAST USE DATE: (B)(6) 2023. 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: E0402 ALSO REFERS TO CONSUMER ALLEGED ABOUT "ALLERGIC REACTION (HIVES SUBSUMED)¿. 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 22 YEAR OLD FEMALE CONSUMER REPORTED THAT SHE STARTED USING NEUTROGENA STUBBORN ACNE ULTRA THIN BLEMISH PATCH DOTS FOR HER FACE ON (B)(6) 2023. CONSUMER EXPERIENCED ALLERGIC REACTION THAT DEVELOPED INTO HIVES ON (B)(6) 2023. AS PER CONSUMER, SHE USED OTHER NON DEVICE PRODUCTS AT THE SAME TIME THAT SHE ALLEGED COULD HAVE CAUSED OR CONTRIBUTED TO THE SYMPTOMS. CONSUMER REPORTED THAT SHE WENT TO URGENT CARE AND HEALTH CASE PROFESSIONAL (HCP) RECOMMENDED TO APPLY A CREAM AND GAVE HER AN UNKNOWN STEROID SHOT/INJECTION. CONSUMER ALSO MENTIONED THAT SYMPTOMS IMPROVED AFTER SHE STOPPED USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986585 NEUTROGENA STUBBORN ACNE ULTRA THIN BLEMISH PATCH DRESSING, WOUND, OCCLUSIVE NAD JOHNSON & JOHNSON CONSUMER INC 070501064368 070501064368

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Required Intervention NEUTROGENA HEALTHY SKIN LIQUID MAKEUP SPF20| NEUTROGENA HYDRO BOOST HYDRATING GEL CLEANSER| NEUTROGENA HYDRO BOOST WATER GEL| NEUTROGENA STUBBORN ACNE AM TREATMENT| NEUTROGENA STUBBORN MARKS PM TREATMENT| NEUTROGENA STUBBORN TEXTURE DAILY CLEANSER| NTG CLEAR COMPLEXION ANTI-O GUMMY W ZINC| NTG CLEAR FACE BREAKOUT FREE OIL FREE SUNSCREEN| SEE H10 FOR FULL DETAILS