BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND BANDAGES WATERBLOCK FLEX BANDAGES

    MDR report key: 12379924 · Received August 27, 2021

    Report

    Report Number
    8041154-2021-00026
    Event Type
    Injury
    Date Received
    August 27, 2021
    Report Date
    September 27, 2021
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    UDI-DI
    381371190621
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. 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 MAY 13, 2021. THIS IS 1 OF 3 FOLLOW-UP (01) MED-WATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCHES 8041154-2021-00026, 8041154-2021-00027, 8041154-2021-00028. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCHES. 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 IDENTIFIER, AGE WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING.(B)(6). UDI #: (B)(4). UPC #: (B)(6). LOT #: 1331B. 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.(B)(4). THIS IS 1 OF 3 MED-WATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCHES 8041154-2021-00027, 8041154-2021-00028. ALSO, SEE MEDWATCH 8041154-2021-00029 FOR PAST ALLERGIC REACTION. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCHES. 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

    CONSUMER REPORTED ON BEHALF OF HER HUSBAND WHO HAD ALLERGIC REACTION AFTER USING BAND AID BRAND BANDAGES WATERBLOCK FLEX ADHESIVE COVER 6CT USA 381371190621 TO COVER A WOUND FROM SURGERY. WIFE INQUIRED ABOUT WHAT WAS IN IT THAT CAUSING THE ALLERGIC REACTION. HE HAD TERRIBLE HIVES AND ITCHING. THE PATIENT USED 3 BAND-AIDS AT A TIME IN A DAY. CONSUMER VISITED DOCTOR AND WAS PRESCRIBED A MEDICATION. THIS IS 1 OF 3 MED-WATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCHES 8041154-2021-00027, 8041154-2021-00028. ALSO, SEE MEDWATCH 8041154-2021-00029 FOR PAST ALLERGIC REACTION. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276397 BAND AID BRAND BANDAGES WATERBLOCK FLEX BANDAGES TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC 381371190621 1331B 381371190621

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention