BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID PLASTIC COMFORT FLEX BANDAGES

    MDR report key: 15336401 · Received September 1, 2022

    Report

    Report Number
    8041154-2022-00009
    Event Type
    Injury
    Date Received
    September 1, 2022
    Date of Event
    June 9, 2022
    Report Date
    September 13, 2022
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    UDI-DI
    62600061805
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THIS REPORT IS FOR ONE (BAND-AID PLASTIC COMFORT FLEX ASSORT 80S CAN 62600061805 6260006180CAA 6260006180CAA, LOT/CTRL # 1531B). 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). UDI #: (B)(4). UPC # 62600061805. LOT # 1531B. EXPIRATION DATE: NA. 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 HAS BEEN REQUESTED. (B)(4). OUT OF AN ABUNDANCE OF CAUTION THIS EVENT IS BEING REPORTED DUE TO MUPIROCIN CNG 2% 15G BEING USED AS TREATMENT. ALTHOUGH THE EVENT DID NOT RESULT IN HEALTH CARE PROFESSIONAL CONSULTATION, THE CONSUMER DID PROVIDE A PHARMACY RECEIPT WITH MUPIROCIN CNG 2% 15G. ALTHOUGH THIS IS AN OTC IN SOME COUNTRIES, IT IS POTENTIALLY A PRESCRIPTION ANTIBIOTIC CREAM IN THE USA. THEREFORE, EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION FOR PRESCRIPTION ANTIBIOTIC CREAM. THIS IS 1 OF 2 MED-WATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 8041154-2022-00010. THE SAME PATIENT 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.

    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. H4, H6: 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 JUNE 2, 2021. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #1 MEDWATCH, AN ADDITIONAL FOLLOW- UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    A MALE CONSUMER REPORTED AN EVENT WITH BAND-AID PLASTIC COMFORT FLEX ASSORT BANDAGES. CONSUMER STARTED USING BANDAGES ON (B)(6) 2022 TO PROTECT/COVER THE WOUND. CONSUMER ALLEGED THAT WHEN HE REMOVED THE BANDAGE AFTER 24 HOURS, THE SKIN UNDER THE GLUE CAME OFF OR PEELED OFF AND IT CAUSED DISCOMFORT AND ANXIETY ON ALL SIDES. CONSUMER REPORTED USING TWO BANDAGES TO MAKE AN X SHAPE AND THE SKIN TORE OFF. CONSUMER TREATED THE EVENT WITH AN ANTIBIOTIC CREAM. ON (B)(6) 2022, CONSUMER PROVIDED A PHARMACY RECEIPT. THE RECEIPT WAS ISSUED ON (B)(6) 2022 BY PROXIM PHARMACY AND IT LISTED ANTIBIOTIC CREAM - MUPIROCIN CNG 2% 15G. CONSUMER IS STILL NOT RECOVERED AT THE TIME OF REPORTING. THIS IS 1 OF 2 MED-WATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 8041154-2022-00010. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2634722 BAND AID PLASTIC COMFORT FLEX BANDAGES TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC 62600061805 1531B 62600061805

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention