BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB TOUGH STRIPS WATERPROOF

    MDR report key: 21917940 · Received April 28, 2025

    Report

    Report Number
    8041154-2025-00003
    Event Type
    Injury
    Date Received
    April 28, 2025
    Report Date
    April 28, 2025
    Manufacturer
    KENVUE BRANDS, LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. A2, A3, A4, A5 AND A6: PATIENT AGE, SEX, GENDER, WEIGHT, ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR ONE (1) BAND-AID TOUGH STRIPS WATERPROOF UNSPECIFIED USA NOT APPLICABLE BATGSTUSUNSP, LOT NUMBER ¿ NI. D4: 510(K) EXEMPT DEVICE I COMPLAINT. UDI AND LOT NUMBER ARE NOT AVAILABLE FOR REPORTING. 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 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 A LOT NUMBER. H6: E1901 ALSO REFERS TO THE CONSUMER ALLEGED FOR "SKIN STRUCTURE AND SOFT TISSUE INFECTION AND SKIN TAG WAS ACTUALLY DEER TICK /BLOOD WORK CAME BACK POSITIVE FOR LYME DISEASE". E2402 REFERS TO THE CONSUMER ALLEGED FOR "INTENTIONAL MISUSE/OFF-LABEL USE" OF THE PRODUCT. THIS CASE IS BEING REPORTED AS AN OVER ABUNDANCE OF CAUTION. THE CAUSALITY TO THE DEVICE PRODUCT IS NOT RELATED. HOWEVER, GIVEN THE TREATMENT AND DIAGNOSIS DURING USE THIS EVENT WILL BE SUBMITTED ACCORDINGLY. IT WAS REPORTED THAT THE CONSUMER USED THE PRODUCT ¿TO SMOTHER WHAT HE/SHE THOUGHT WAS A SKIN TAG ON HIS/HER NECK¿ AND WORE THE PRODUCT FOR 11 DAYS (INTERPRETED AS MISUSE). IT WAS LATER CONFIRMED THAT WHAT CONSUMER THOUGHT TO BE A SKIN TAG WAS ACTUALLY A ¿DEER TICK¿ CLINGING ON TO SKIN AND SUBSEQUENTLY TESTED POSITIVE FOR TICK-BORNE BACTERIAL INFECTION OF LYME DISEASE (CODED TO BACTERIAL INFECTION - INFECTION/DISEASE - SKIN STRUCTURE AND SOFT TISSUE INFECTION DUE TO CODING LIMITATION). CONSUMER WAS TREATED WITH A ¿MONTH OF DOXYCYCLINE¿ (ROUTE NOT SPECIFIED; INTERPRETED AS ORAL). 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 CONSUMER OF UNKNOWN AGE OR GENDER REPORTED USING A BAND-AID TOUGH STRIP WATERPROOF PRODUCT TO SMOTHER WHAT WAS PERCEIVED INITIALLY AS A SKIN TAG ON THE CONSUMER&APOS' NECK. CONSUMER STATED THEY WORE THE PRODUCT FOR 11 DAYS AND NIGHTS. CONSUMER REPORTED THE PRODUCT HAD FALLEN OFF. CONSUMER PLACED PRODUCT AND SKIN TAG IN A BAGGIE TO BRING TO DOCTOR&APOS' OFFICE FOR A BIOPSY. CONSUMER REPORTED NEXT DAY THE SKIN TAG WAS CRAWLING AROUND THE BAGGIE AND IT WAS IDENTIFIED AS A DEER TICK FROM THE CONSUMER¿S NECK AND NOT A SKIN TAG. CONSUMER WAS TESTED AND WAS POSITIVE FOR LYME DISEASE AND TREATED WITH ORAL DOXYCYCLINE FOR ONE MONTH. CONSUMER REPORTED THERE IS NO LONG-TERM SIDE EFFECTS AND HAS HEALED FROM EVENT. THIS CASE IS BEING REPORTED AS AN OVER ABUNDANCE OF CAUTION. THE CAUSALITY TO THE DEVICE PRODUCT IS NOT RELATED. HOWEVER, GIVEN THE TREATMENT AND DIAGNOSIS DURING USE THIS EVENT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429473 BAB TOUGH STRIPS WATERPROOF TAPE AND BANDAGE, ADHESIVE KGX KENVUE BRANDS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention