BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB FLEXIBLE FABRIC BANDAGES

    MDR report key: 19765382 · Received July 17, 2024

    Report

    Report Number
    2214133-2024-00032
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    May 26, 2024
    Report Date
    July 19, 2024
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    UDI-DI
    381370056850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 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. A1, A3B, A4, A5 AND A6: PATIENT IDENTIFIER, GENDER, WEIGHT, PATIENT ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1: THIS REPORT IS FOR ONE (1) J&J BAND AID BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC STRIPS 10CT USA 381370056850 381370056850USA 381370056850USA, LOT NUMBER 221114. D4: UDI #: (B)(4); UPC #: 381370056850, LOT #: 221114, EXP. DATE: NA. D10: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: 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. H6: HEALTH EFFECT CLINICAL CODES: E1721 ALSO REFERS TO CONSUMER ALLEGED ¿WHEN REMOVING THE BAND AID IT REMOVED SKIN¿ E2402 REFERS TO CONSUMER " INTENTIONAL MISUSE/OFF-LABEL USE" OF THE PRODUCT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL 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 FOR 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 NOVEMBER 14, 2022. RAW MATERIAL AND COMPONENT RECORDS WERE REVIEWED AND WERE FOUND ACCEPTABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #1 MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    A FEMALE CONSUMER REPORTED THE EVENT WITH BAND AID BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC STRIPS 10 COUNT WHICH OCCURRED ON (B)(6) 2024 . ONE BANDAGE WAS APPLIED JUST ONE TIME FOR BRUISE WITH A LITTLE CUT ON (B)(6) 2024 . CONSUMER REPORTED THAT WHEN SHE WAS SLOWLY REMOVING THE BAND AID, SOME OF THE SKIN WAS ALREADY COMING OUT TOGETHER WITH THE ADHESIVE. THEN THE SKIN BECAME INFECTED. CONSUMER USED NEOSPORIN, APPLIED PEROXIDE AND CLEANED WITH ALCOHOL. CONSUMER ALSO REPORTED THAT A DOCTOR RECOMMENDED TO CLEAN THE AREA WITH ANTI-BACTERIAL SOAP AND CHANGE THE BANDAGE THREE TIMES A DAY AND PRESCRIBED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367168 BAB FLEXIBLE FABRIC BANDAGES TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC 381370056850 221114 381370056850

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention