BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUTROGENA STUBBORN ACNE ULTRA THIN BLEMISH PATCH

    MDR report key: 18950197 · Received March 21, 2024

    Report

    Report Number
    2214133-2024-00010
    Event Type
    Injury
    Date Received
    March 21, 2024
    Report Date
    March 21, 2024
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    NAD
    UDI-DI
    070501064375
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 AN 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. 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 MARCH 23, 2022. THIS IS ONE OF FIVE FOLLOW-UP MEDWATCHES BEING SUBMITTED AS FIVE DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCHES 2214133-2024-00011; 2214133-2024-00012; 2214133-2024-00013; 2214133-2024-00014. THE SAME PATIENT AND EVENT IS REPRESENTED IN EACH MEDWATCH. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP MEDWATCH, AN ADDITIONAL FOLLOW- UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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 AN 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: WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR ONE (NEUTROGENA STUBBORN ACNE ULTRA THIN BLEMISH PATCH ASSORTED 16CT USA 070501064375 (B)(6), LOT/CTRL # 2422C). D4: UDI #: (B)(4). UPC #: 070501064375 LOT #: 2422C EXP DATE: NA 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 HAS BEEN REQUESTED. H6: HEALTH EFFECT CLINICAL CODE: E0402 ALSO REFERS TO CONSUMER ALLEGED FOR "ALLERGIC REACTION AND FACE TURNED RED AND BROKE OUT". THIS IS ONE OF FIVE MEDWATCHES BEING SUBMITTED AS FIVE DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCHES 2214133-2024-00010; 2214133-2024-00011; 2214133-2024-00012; 2214133-2024-00013; 2214133-2024-00014. THE SAME PATIENT AND EVENT IS REPRESENTED IN EACH MEDWATCH. 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 MALE CONSUMER REPORTED AN ALLERGIC REACTION WITH NEUTROGENA STUBBORN ACNE ULTRA THIN BLEMISH PATCHES ASSORTED. IT WAS REPORTED THAT CONSUMER APPLIED FIVE CIRCLES ONE TIME, FIVE WEEKS AGO ON HIS FACE FOR MINOR BLEMISHES AND IT CAUSED AN IMMEDIATE ALLERGIC REACTION. CONSUMER REPORTED THAT HIS FACE TURNED RED AND BROKE OUT. CONSUMER SOUGHT MEDICAL INTERVENTION AND WAS TREATED WITH AN UNSPECIFIED ANTIBIOTIC FOR THREE WEEKS. CONSUMER¿S SYMPTOMS HAVE WORSENED AT THE TIME OF THIS REPORTING. THIS IS ONE OF FIVE MEDWATCHES BEING SUBMITTED AS FIVE DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCHES 2214133-2024-00010; 2214133-2024-00011; 2214133-2024-00012; 2214133-2024-00013; 2214133-2024-00014. THE SAME PATIENT AND EVENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523154 NEUTROGENA STUBBORN ACNE ULTRA THIN BLEMISH PATCH DRESSING, WOUND, OCCLUSIVE NAD JOHNSON & JOHNSON CONSUMER INC 070501064375 2422C 070501064375

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention