BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND INFECTION DEFENSE LARGE ADHESIVE COVER WITH NEOSPORIN

    MDR report key: 12165563 · Received July 14, 2021

    Report

    Report Number
    8041154-2021-00017
    Event Type
    Injury
    Date Received
    July 14, 2021
    Date of Event
    June 27, 2021
    Report Date
    August 3, 2021
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    UDI-DI
    381371192533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP 02 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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 OCTOBER 21, 2020. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #1 MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. PATIENT BIRTH YEAR - (B)(6). UDI #: (B)(4). UPC #:381371192533. LOT #: 2950B EXPIRATION DATE: 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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 ISSUE WITH A BAND AID BRAND INFECTION DEFENSE LARGE ADHESIVE COVER WITH NEOSPORIN TO COVER A SCRATCH AROUND THE BREAST AREA. CONSUMER REPORTED THAT ON (B)(6) 2021 THE PRODUCT RIPPED THE SKIN ON BOTH SIDES UPON REMOVAL AND PARTS OF THE SKIN WAS BUBBLED UP. THE CONSUMER SOUGHT MEDICAL ATTENTION AND WAS PRESCRIBED AN UNSPECIFIED ANTIBIOTIC FOR TREATMENT. CONSUMER IS STILL EXPERIENCING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064952 BAND AID BRAND INFECTION DEFENSE LARGE ADHESIVE COVER WITH NEOSPORIN TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC 381371192533 2950B 381371192533

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention