BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB FLEXIBLE FABRIC BANDAGES

    MDR report key: 21663842 · Received March 21, 2025

    Report

    Report Number
    1000599868-2025-00002
    Event Type
    Injury
    Date Received
    March 21, 2025
    Date of Event
    January 1, 2025
    Report Date
    March 21, 2025
    Manufacturer
    KENVUE BRANDS, LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    KENVUE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH KENVUE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, KENVUE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, KENVUE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IN AUGUST 2023 JOHNSON & JOHNSON¿S CONSUMER HEALTH BUSINESS SEPARATED FROM JOHNSON & JOHNSON, AND WE BECAME AN INDEPENDENT PUBLIC COMPANY, KENVUE. AS PART OF OUR ONGOING EVOLUTION, KENVUE UPDATED THE NAME OF ITS US OPERATING COMPANY, JOHNSON & JOHNSON CONSUMER INC. (¿JJCI¿) TO ¿KENVUE BRANDS LLC¿ ON OCTOBER 28, 2024. KENVUE RECENTLY MOVED TO ITS NEW CORPORATE HEADQUARTERS IN SUMMIT NJ. ITS PREVIOUS CORPORATE HEADQUARTERS WAS 199 GRANDVIEW ROAD, SKILLMAN, NJ 08558. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A4, A5, A6: PATIENT WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR ONE (BAB FLEXIBLE FABRIC ASSORTED 100 CT USA 381371150786 8137115078USA 8137115078USA, LOT/CTRL # 220312). D4: 510(K) EXEMPT DEVICE I COMPLAINT. UDI AND EXPIRATION DATE ARE NOT AVAILABLE FOR REPORTING. UDI: (B)(4). UPC # 381371150786. EXPIRATION DATE: NI. LOT #: 220312. D9: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 12, 2022. H6: E1718 REFERS TO THE CONSUMER ALLEGED FOR ADDITIONAL SORES OPENING/EXACERBATED THE CONDITIONS BY CAUSING ADDITIONAL BREAKDOWN OF SKIN (SKIN INJURY). E2402 REFERS TO CONSUMER "INTENTIONAL MISUSE/OFF-LABEL USE" OF THE PRODUCT. CONSUMER USED THE PRODUCT TO COVER A PIMPLE AND REPORTED BREAKDOWN OF SKIN, SORES OPENING AND HEALING FOR TWO MONTHS. HEALTH CARE PROFESSIONAL CONSULTATION REPORTED AND EVENTS TREATED WITH DOXYCYCLINE, MUPIROCIN, NEOSPORIN AND USING NONSTICK PADS. NO DIRECT REPORT OF ANY NECROSIS/GANGRENE. NO REPORT OF HOSPITALIZATION OR ANY SIGNIFICANT MEDICAL TREATMENT OR INTERVENTION WAS REPORTED. TWO MEDWATCHES (B)(4) ARE BEING SUBMITTED AS TWO DEVICES WERE INVOLVED WITH THE SAME EVENT DESCRIPTION AND CONSUMER. SEE MEDWATCH (B)(4). 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 42-YEAR-OLD CONSUMER REPORTED AN EVENT WITH BAND AID FLEXIBLE FABRIC BANDAGES. IT WAS REPORTED THAT CONSUMER STARTED USING THE PRODUCT ON 06-JUN-2024 TO COVER A PIMPLE/IRRITATED WOUND UNDER BREAST TO PROTECT FROM RUBBING. CONSUMER APPLIED 1-2 BAND-AIDS PER APPLICATION. CONSUMER REPORTED THAT ADVERSE REACTIONS BEGAN ON 01-JAN-2025 AND PRODUCT CREATED ADDITIONAL SORES/OPENINGS AND EXACERBATED THE CONDITIONS BY CAUSING ADDITIONAL BREAKDOWN OF SKIN. CONSUMER STATED HEALING TOOK TWO MONTHS. CONSUMER SOUGHT MEDICAL INTERVENTION AND WAS TREATED WITH DOXYCYCLINE 100MG (FOR 21 DAYS), MUPIROCIN (2 TIMES A DAY), IN ADDITION TO NEOSPORIN AND USING NONSTICK PADS AT APPLICATION SITE. CONSUMER REPORTED SYMPTOMS HAVE WORSENED AFTER PRODUCT WAS LAST USED. THERE IS NO ADDITIONAL INFORMATION WITH REGARDS TO OUTCOME FOR THIS CONSUMER. TWO MEDWATCHES (B)(4) ARE BEING SUBMITTED AS TWO DEVICES WERE INVOLVED WITH THE SAME EVENT DESCRIPTION AND CONSUMER. SEE MEDWATCH (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620540 BAB FLEXIBLE FABRIC BANDAGES TAPE AND BANDAGE, ADHESIVE KGX KENVUE BRANDS, LLC 381371150786 220312

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention