BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB TOUGH STRIPS WATERPROOF

    MDR report key: 12373766 · Received August 26, 2021

    Report

    Report Number
    8041154-2021-00023
    Event Type
    Injury
    Date Received
    August 26, 2021
    Report Date
    August 27, 2021
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    UDI-DI
    381370048336
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. ADDITIONAL INFORMATION SECTION: B5: THREE MEDWATCHES (8041154-2021-00023; 8041154-2021-00031; 8041154-2021-00032) ARE BEING SUBMITTED AS THREE DEVICES WERE INVOLVED WITH THE SAME EVENT DESCRIPTION. SEE MEDWATCHES 8041154-2021-00023 & 8041154-2021-00031 & 8041154-2021-00032. IT SHOULD BE NOTED, THAT THIS SUBMISSION IS POTENTIALLY THE SAME EVENT/CONSUMER THAT WAS SUBMITTED UNDER 8041154-2021-00023 & 8041154-2021-00031 & 8041154-2021-00032. THE SAME CONSUMER IS POTENTIALLY REPRESENTED IN EACH ONE OF THOSE MEDWATCHES. ALTHOUGH THE EVENTS ARE VERY SIMILAR IN NATURE AND THEY ARE SOCIAL MEDIA REVIEWS, IT CANNOT BE DETERMINED CONCLUSIVELY THAT THESE ARE THE SAME CONSUMER. THEREFORE, THESE MEDWATCHES WILL BE SUBMITTED OUT OF AN ABUNDANCE OF CAUTION AND WILL BE TREATED AS INDEPENDENT SUBMISSIONS AND COMPLAINTS IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP (01) MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THREE MEDWATCHES (8041154-2021-00023 & 8041154-2021-00031 & 8041154-2021-00032) ARE BEING SUBMITTED AS THREE DEVICES WERE INVOLVED WITH THE SAME EVENT DESCRIPTION. SEE MEDWATCHES 8041154-2021-00023 & 8041154-2021-00031 & 8041154-2021-00032. IT SHOULD BE NOTED, THAT THIS SUBMISSION IS POTENTIALLY THE SAME EVENT/CONSUMER THAT WAS SUBMITTED UNDER 8041154-2021-00023 & 8041154-2021-00031 & 8041154-2021-00032. THE SAME CONSUMER IS POTENTIALLY REPRESENTED IN EACH ONE OF THOSE MEDWATCHES. ALTHOUGH THE EVENTS ARE VERY SIMILAR IN NATURE AND THEY ARE SOCIAL MEDIA REVIEWS, IT CANNOT BE DETERMINED CONCLUSIVELY THAT THESE ARE THE SAME CONSUMER. THEREFORE, THESE MEDWATCHES WILL BE SUBMITTED OUT OF AN ABUNDANCE OF CAUTION AND WILL BE TREATED AS INDEPENDENT SUBMISSIONS AND COMPLAINTS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT IDENTIFIER, AGE AT TIME OF EVENT, GENDER, WEIGHT AND ETHNICITY WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE (1) BAB TOUGH STRIPS WATERPROOF 20S USA 381370048336 8137004833USA 8137004833USA, LOT NUMBER N/A. UDI # (B)(4). UPC-381370048336. LOT NUMBER - NI. EXP- 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 COULD NOT BE COMPLETED WITHOUT LOT NUMBER. (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 · 1

    CONSUMER REPORTED AN EVENT WITH BAND AID BANDAGE TOUGH STRIPS WATERPROOF. AFTER ACCIDENTALLY CUTTING HIS/HER ARM ON THE JOB, THE CONSUMER WENT HOME, CLEANED OUT THE WOUND AND APPLIED A BANDAGE. AFTER 2 DAYS, THE CONSUMER¿S SKIN BECAME IRRITATED AND THE CONSUMER DEVELOPED A VERY ITCHY RASH THAT WITHIN A WEEK SPREAD ACROSS THE ENTIRE ARM, DOWN THE LEFT SIDE TORSO AND ON THIGHS. CONSUMER WENT TO URGENT CARE, WHERE WAS TOLD THAT THE CONSUMER WAS ON THE BORDER OF ANAPHYLACTIC SHOCK. AS OF THREE WEEKS, THE CONSUMER¿S SKIN IS STILL TENDER AND BRIGHT PINK. CONSUMER IS ON ANTIBIOTICS, TWO SEPARATE ANTIHISTAMINES AND NEEDS TO CARRY AN EPIPEN AROUND WITH HIM/HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270472 BAB TOUGH STRIPS WATERPROOF TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC 381370048336 381370048336

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention