BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND PLASTIC EXTRA WIDE 40 QUILT AP 9300607171341

    MDR report key: 8662800 · Received June 3, 2019

    Report

    Report Number
    8041154-2019-00053
    Event Type
    Injury
    Date Received
    June 3, 2019
    Report Date
    May 11, 2019
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE AT TIME OF EVENT, WEIGHT AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR (BAND AID BRAND PLASTIC EXTRA WIDE 40 QUILT AP 9300607171341 3720612603APA 3720612603APA). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (BAB PLASTIC ASSORTED 20S USA 381371042265 8137104226USA 8137104226USA). (B)(4). EXP DATE = 31-DEC-2021, LOT NUMBER = (10)190102A. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: DRUG: UNKNOWN BLOOD PRESSURE TABLE & UNKNOWN DOSAGE. 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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (BAB PLASTIC ASSORTED 20S USA 381371042265 8137104226USA). THIS IS ONE OF SIX MEDWATCHES BEING SUBMITTED AS THREE BAND AID BRAND PLASTIC EXTRA WIDE & THREE BAND-AID CLEAR STRIPS WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 8041154-2019-00048 & 8041154-2019-00049, 8041154-2019-00050, 8041154-2019-00051, 8041154-2019-00052 & 8041154-2019-00053. THE SAME PATIENT IS REPRESENTED IN EACH. 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

    A MALE CONSUMER CALLED TO REPORT AN EVENT WHILE USING BAND AID BRAND PLASTIC EXTRA WIDE. THE CONSUMER STATED HE HAD A LEGION ON HIS THROAT AND USED BAND-AID CLEAR STRIPS. THE CONSUMER HAD DIFFICULTY REMOVING THE PRODUCT. THE CONSUMER STATED THAT HIS SKIN WAS IRRITATED AND INFLAMED. THE CONSUMER SOUGHT MEDICAL ATTENTION FROM HIS HEALTH CARE PROVIDER (HCP). THE CONSUMER WAS PRESCRIBED ELOCON OINTMENT TO TREAT THE SYMPTOMS. THE SYMPTOMS HAVE RESOLVED. THE HCP RECOMMENDED A BIOPSY FOR HIS PRE-EXISTING LESION. THIS IS ONE OF SIX MEDWATCHES BEING SUBMITTED AS THREE BAND AID BRAND PLASTIC EXTRA WIDE & THREE BAND-AID CLEAR STRIPS WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 8041154-2019-00048 & 8041154-2019-00049, 8041154-2019-00050, 8041154-2019-00051, 8041154-2019-00052 & 8041154-2019-00053. THE SAME PATIENT IS REPRESENTED IN EACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455108 BAND AID BRAND PLASTIC EXTRA WIDE 40 QUILT AP 9300607171341 ADHESIVE BANDAGES KGX JOHNSON & JOHNSON CONSUMER INC 9300607171341 190102A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN BLOOD PRESSURE TABLET