BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB CLEAR WATER BLOCK PLUS

    MDR report key: 9218849 · Received October 22, 2019

    Report

    Report Number
    8041154-2019-00083
    Event Type
    Injury
    Date Received
    October 22, 2019
    Report Date
    October 31, 2019
    Manufacturer
    JOHNSON AND JOHNSON CONSUMER INC.
    Product Code
    KGX
    UDI-DI
    381370056591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 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. 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 (B)(6)2017. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS FOLLOW-UP MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT ETHNICITY AND RACE WAS NOT PROVIDED FOR REPORTING. (B)(4). EXPIRATION DATE= NI. LOT NUMBER = 0177B. 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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. (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

    A FEMALE CONSUMER REPORTED AN EVENT WITH BAND-AID BRAND CLEAR WATER BLOCK PLUS ADHESIVE BANDAGES. THE CONSUMER USED THE PRODUCT TO COVER A SMALL CUT ON HER ARM. WHILE REMOVING THE PRODUCT, IT TORE OFF HER SKIN. THE CONSUMER WENT TO URGENT CARE AND A HEALTH CARE PROFESSIONAL APPLIED BACTINE AND BANDAGED THE WOUND. THE CONSUMER IS STILL EXPERIENCING PAIN AND OOZING FROM THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014091 BAB CLEAR WATER BLOCK PLUS ADHESIVE BANDAGE KGX JOHNSON AND JOHNSON CONSUMER INC. 381370056591 0177B 381370056591

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention