BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB TOUGH STRIPS

    MDR report key: 17037794 · Received June 1, 2023

    Report

    Report Number
    8041154-2023-00009
    Event Type
    Injury
    Date Received
    June 1, 2023
    Report Date
    June 14, 2023
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC.
    Product Code
    KGX
    UDI-DI
    381370044246
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. 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 18, 2022. RAW MATERIAL AND COMPONENT RECORDS WERE REVIEWED AND WERE FOUND ACCEPTABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS IS ONE OF THREE MEDWATCH FOLLOW-UPS BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 8041154-2023-00010 & 8041154-2023-00011. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH FOLLOW-UP.

    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. A2: PATIENT AGE AT TIME OF EVENT WAS 85; DEC 1937 WAS PROVIDED BUT EXACT DATE NOT GIVEN. A3, A4, A5: PATIENT GENDER, WEIGHT AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR BAB TOUGH STRIPS EXTRA LARGE 10S USA 381370044246 8137004424USA 8137004424USA LOT/CTRL # 2282B. D4: UDI# (B)(4). UPC#: 381370044246. LOT#: 2282B. EXPIRATION DATE: NA. D10: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. H6: HEALTH EFFECT CLINICAL CODES: E172006 ALSO REFERS TO CONSUMER ALLEGED ABOUT & HIVES SUBSUMED RED RASH AND IRRITATION. E2402 REFERS TO CONSUMER "INTENTIONAL MISUSE/OFF-LABEL USE OF THE PRODUCT. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 8041154-2023-00010 & 8041154-2023-00011. 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.

    Description of Event or Problem · 0

    CONSUMER REPORTED AN EVENT WITH BAND AID BANDAGES EXTRA LARGE TOUGH STRIPS. IT WAS REPORTED THAT THE CONSUMER APPLIED THE BANDAGES AFTER A BIOPSY ON WARTS. CONSUMER ALLEGED A PRETTY VIOLENT REACTION TO THE PRODUCT. THE ADHESIVE APPARENTLY REALLY IRRITATED HER SKIN, GOT A BRIGHT RED RASH BREAKING OUT IN HIVES ON TOP OF THE RASH OR AS PART OF THE RASH. CONSUMER VISITED HEALTH CARE PROFESSIONAL (HCP) AND WAS GIVEN UNKNOWN MEDICINE FOR TREATMENT. CONSUMER IS NO LONGER EXPERIENCING ANY SYMPTOMS. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 8041154-2023-00010 & 8041154-2023-00011. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1557890 BAB TOUGH STRIPS TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC. 381370044246 2282B 381370044246

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Unknown Required Intervention