BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB FLEXIBLE FABRIC BANDAGES

    MDR report key: 16760726 · Received April 18, 2023

    Report

    Report Number
    1000599868-2023-00003
    Event Type
    Injury
    Date Received
    April 18, 2023
    Report Date
    March 26, 2023
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    UDI-DI
    381370044444
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. A4, A5: AGE: 58 YEARS OLD. WEIGHT AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR ONE (1) BAB FLEXIBLE FABRIC 1IN 100S USA 381370044444, 8137004444USA, 8137004444USA, LOT/CTRL # 210605. D4: UDI #: (B)(4). UPC # 381370044444. EXPIRATION DATE: NA. LOT #: 210605. D10: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 JUNE 5, 2021. H6: HEALTH EFFECT CLINICAL CODE: E1721 ALSO REFERS TO CONSUMER ALLEGED ABOUT "LOOKED LIKE THREE LAYERS OF SKIN WAS REMOVED, WAS BLEEDING PROFUSELY, HCP STATED WOUND WAS DEEP" 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.

    Description of Event or Problem · 0

    A 58 YEAR OLD MALE CONSUMER HAD TOENAIL SURGERY ON HIS BIG TOES FOR INGROWN TOENAILS AND WAS USING BAND AIDE FLEXIBLE FABRIC 1IN ON (B)(6) 2023 AS PART OF THE DRESSING CHANGES. CONSUMER STATED HE WAS SOAKING THE BIG TOE ON THE RIGHT, FOR A MEDICAL SITUATION AT THE TOENAIL. AFTER SOAKING HE APPLIED AN ANTIBIOTIC CREAM ON IT AND USED ONE BAND AID. CONSUMER CHANGED HIS DRESSING TWICE PER DAY, ONCE IN THE MORNING AND EVENING, PER HEALTH CARE PROFESSIONAL (HCP) INSTRUCTION. CONSUMER STATED HE WENT TO AN URGENT CARE FACILITY DUE TO THE REMOVAL OF BAND AID. CONSUMER SAID IT LOOKED LIKE IT REMOVED THREE LAYERS OF SKIN AND WAS BLEEDING PROFUSELY. HE STATED IT WAS A MESS AND HE THOUGHT IT LOOKED LIKE IT WAS DOWN TO THE MUSCLE. CONSUMER STATED HE NEEDED PROFESSIONAL INTERVENTION TO HELP WITH THE BLEEDING AND CARE OF THE WOUND. THE URGENT CARE HCP STATED THAT THE WOUND WAS DEEP AND PROVIDED INSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492934 BAB FLEXIBLE FABRIC BANDAGES TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC 381370044444 210605 381370044444

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention