BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB ACTIV FLEX ADVANCED ADHESIVE BANDAGE

    MDR report key: 18980490 · Received March 26, 2024

    Report

    Report Number
    2214133-2024-00015
    Event Type
    Injury
    Date Received
    March 26, 2024
    Date of Event
    March 7, 2024
    Report Date
    April 2, 2024
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    NAD
    UDI-DI
    381370044147
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 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. H2, H4, H6: THE PRODUCT WAS MANUFACTURED ON JULY 10, 2014 AND WAS BEYOND THE SHELF LIFE OF JUN-2017 AT THE TIME OF THIS REPORTING. BASED ON THE MANUFACTURING SITES QUALITY AGREEMENT, THE SITE KEEPS THE BATCH DOCUMENTATION FOR ONE YEAR AFTER THE SHELF LIFE THEREFORE THE SITE DOESN'T HAVE THE BATCH DOCUMENTATION FOR THE REPORTED LOT TO CONDUCT INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #1 MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS IS 1 OF 2 MED-WATCH FOLLOW-UPS (BAB 01) BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2214133-2024-00016. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH FOLLOW-UP.

    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. A4, A5: WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR ONE (BAB ACTIV FLEX ADVANCED ADHESIVE BANDAGES 10CT USA 381370044147 8137004414USC, LOT/CTRL # 1904C). D4: UDI #: (B)(4). UPC #: 381370044147. LOT #: 1904C. EXP DATE: NA. D9: 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. DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. H6: HEALTH EFFECT CLINICAL CODE: E1719 REFERS TO "TOE WAS ALMOST LIKE IT'S INFECTED/THE TOE LOOKED INFECTED (SWELLING SUBSUME). HEALTH EFFECT CLINICAL CODE: E1703 REFERS TO BIG BLISTER ON TOE. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2214133-2024-00016. 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 · 0

    A 68-YEAR-OLD FEMALE CONSUMER REPORTED ADVERSE EVENT WITH BAND AID ACTIVE FLEX ADVANCED ADHESIVE BANDAGES. CONSUMER REPORTED THAT SHE APPLIED TWO BANDAGES ON (B)(6) 2024, ONE AT A TIME ON HER TOES FOR TWO DAYS. CONSUMER REPORTED THAT HER TOE GOT SWOLLEN AND HER TOE BECAME TWICE AS BIG WITH BLISTERS AND LOOKED INFECTED. CONSUMER SOUGHT MEDICAL ATTENTION AND WAS TREATED WITH ANTI-BIOTIC (CEPHALEXIN). CONSUMER DENIED ANY HOSPITALIZATION. CONSUMER¿S SYMPTOMS HAVE STAYED THE SAME AT THE TIME OF THIS REPORTING. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2214133-2024-00016. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297 BAB ACTIV FLEX ADVANCED ADHESIVE BANDAGE DRESSING, WOUND, OCCLUSIVE NAD JOHNSON & JOHNSON CONSUMER INC 381370044147 1904C 381370044147

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention