BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB FLEXIBLE FABRIC BANDAGES

    MDR report key: 16761010 · Received April 18, 2023

    Report

    Report Number
    1000599868-2023-00004
    Event Type
    Injury
    Date Received
    April 18, 2023
    Report Date
    March 29, 2023
    Manufacturer
    JOHNSON & JOHNSON COMPANY INC
    Product Code
    KGX
    UDI-DI
    381370044444
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. PATIENT AGE AT TIME OF EVENT, GENDER, WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE (1) BAB FLEXIBLE FABRIC 1IN 100S USA 381370044444 8137004444USA 8137004444USA, LOT NUMBER 220809. UDI #: (B)(4). UPC #: 381370044444. LOT #: 220809. EXPIRATION DATE: NA. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 AUGUST 9, 2022. HEALTH EFFECT CLINICAL CODE: E2338 ALSO REFERS TO CONSUMER ALLEGED ABOUT "REACTION DESCRIBED AS WOUND GOT WORSE AND AWFUL. 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 CONSUMER REPORTED AN EVENT WITH BAND AID FLEXIBLE FABRIC 1IN. CONSUMER APPLIED BAND AID FLEXIBLE FABRIC ON A WOUND AND ALLEGED IT MADE IT WORSE. CONSUMER STATED THAT THE ENTIRE AREA OF THE WOUND WAS RED AND SWOLLEN AND AWFUL. THE CONSUMER HAD TO GO TO A DOCTOR WHO CONFIRMED IT WAS CAUSED BY THE BAND AID. IT WAS REPORTED THAT, THE CONSUMER NEEDED TO BE TREATED WITH STEROIDS FOR A MINIMUM OF FOUR WEEKS AND THE SCARRING MAYBE PERMANENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562126 BAB FLEXIBLE FABRIC BANDAGES TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON COMPANY INC 381370044444 220809 381370044444

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention