BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID PLASTIC COMFORT FLEX BANDAGES

    MDR report key: 15743556 · Received November 7, 2022

    Report

    Report Number
    8041154-2022-00029
    Event Type
    Injury
    Date Received
    November 7, 2022
    Date of Event
    September 2, 2022
    Report Date
    October 13, 2022
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. AGE AT TIME OF EVENT, WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE BAND-AID PLASTIC COMFORT FLEX ASSORT 80S CAN 62600061805 6260006180CAA 6260006180CAA. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (BAB SHEER COMFORT FLEX ASSORTED 80S USA 381370046691 8137004669USC 8137004669USC). LOT NUMBER IS NOT AVAILABLE. UDI: (B)(4), UPC: 62600061805, EXPIRATION DATE: NA, LOT NUMBER: NI. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 THE LOT NUMBER. THIS IS TWO OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 8041154-2022-00028. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MED-WATCH, AN ADDITIONAL FOLLOW-UP MED-WATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS EVENT INVOLVED A FEMALE CONSUMER USING BAND-AID PLASTIC COMFORT FLEX ASSORTED BANDAGES. ON (B)(6) 2022, THE CONSUMER USED A BAND-AID PLASTIC COMFORT FLEX ASSORTED BANDAGE TO COVER A SMALL CUT ON THE INSIDE OF HER LEFT ANKLE. SHE USED THE BANDAGES TWICE A DAY AND USED 2 BANDAGES IN TOTAL. WITHIN 12 HOURS AFTER THE APPLICATION, THE CONSUMER WAS EXPERIENCING PAINFUL ITCHING. SHE REMOVED THE BANDAGE AND NOTICED THE GAUZE OF THE BANDAGE IRRITATED HER SKIN LEAVING A RED RECTANGLE. THE CONSUMER REPORTED THE BURNING AND ITCHING BECAME SO SEVERE SHE NEEDED A PRESCRIPTION CREAM. ON UNSPECIFIED DATE, THE CONSUMER CONSULTED A HEALTHCARE PROFESSIONAL, WHO PRESCRIBED AN ANTIBIOTIC CREAM. THE CONSUMER DID NOT PROVIDE ANY FURTHER DETAILS REGARDING THE TREATMENT. ON AN UNSPECIFIED DAY IN (B)(6) 2022, SHE HAD RECOVERED. THE CONSUMER DID NOT HAVE ANY MEDICAL CONDITIONS OR RELEVANT MEDICAL HISTORY. THIS IS TWO OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 8041154-2022-00028. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178901 BAND AID PLASTIC COMFORT FLEX BANDAGES TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC 62600061805

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention