BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB FLEXIBLE FABRIC EXTRA LARGE

    MDR report key: 10205946 · Received June 29, 2020

    Report

    Report Number
    1000599868-2020-00004
    Event Type
    Injury
    Date Received
    June 29, 2020
    Date of Event
    May 15, 2020
    Report Date
    June 25, 2020
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    UDI-DI
    381370056850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. CORRECTION, ADDITIONAL INFORMATION AND DEVICE EVALUATION: PRODUCT WAS RETURNED FOR INVESTIGATION. LOT NUMBER AND UPC WERE VERIFIED. THE PRODUCT DID NOT MET SPECIFICATIONS FOR LABELLING SINCE THE TWO RETURNED BAND-AID BOXES STATE MADE IN BRAZIL AND BAND-AIDS INSIDE STATE MADE IN CHINA. VISUAL INSPECTION WAS PERFORMED ON THE RETAIN SAMPLES AND THE RETURNED SAMPLES AND CARTON WAS NOTED AS ¿MADE IN BRAZIL¿ AND STRIPS WAS NOTED AS ¿MADE IN CHINA¿. THE RETAIN SAMPLES DID NOT MET THE SPECIFICATIONS FOR PRODUCT LABELLING. FIELD SAMPLE PHOTOS WERE EVALUATED BY J&J SHANGHAI AND BASED ON INVESTIGATION PERFORMED IT WAS CONCLUDED THAT, THERE WAS A TYPOGRAPHICAL ERROR ON THE CARTON AND THAT IT WAS NOT SUSPECT MIXED PRODUCT. THE COUNTRY ON THE CARTON WAS UPDATED FOR FUTURE LOTS, STARTING WITH 200423. THERE IS NO IMPACT TO THE PRODUCT QUALITY, PATIENT SAFETY OR PROCESS AS A RESULT OF THIS FINDING. THIS IS ONE OF TWO FOLLOW-UP MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 1000599868-2020-00005. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    DURING INVESTIGATION, IT WAS NOTED THAT THE 2 BOXES OF BAND-AID FLEXIBLE FABRIC: EXTRA LARGE LOT 200218 CARTON STATES MADE IN BRAZIL, WHEREAS, THE BAND-AIDS INSIDE THE CARTON STATE MADE IN CHINA.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UPC #: (B)(4), LOT #: 200218, UDI #: (B)(4). (B)(4). 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 FEBRUARY 18, 2020. VISUAL INSPECTION WAS PERFORMED ON THE RETAIN SAMPLES AND THE RETURNED SAMPLES AND ALL RESULTS MET SPECIFICATION. PRODUCT WAS RETURNED FOR INVESTIGATION. LOT NUMBER AND UPC WERE VERIFIED. THE PRODUCT MET SPECIFICATIONS. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 1000599868-2020-00005. 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 · 1

    A FEMALE CONSUMER REPORTED AN EVENT WITH FLEXIBLE FABRIC EXTRA LARGE BAND AID BANDAGES. ON (B)(6) 2020, THE CONSUMER USED THE BANDAGES FOR A CUT. WHEN THE CUT GOT INFECTED, THE CONSUMER SOUGHT MEDICAL ATTENTION THROUGH URGENT CARE AND WAS PRESCRIBED ANTIBIOTICS. THE CONSUMER IS STILL EXPERIENCING SOME REDNESS FROM THE SKIN. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 1000599868-2020-00005. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670074 BAB FLEXIBLE FABRIC EXTRA LARGE TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC 381370056850 200218 381370056850

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention