BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND SHEER BANDAGES

    MDR report key: 9318812 · Received November 13, 2019

    Report

    Report Number
    1000599868-2019-00013
    Event Type
    Injury
    Date Received
    November 13, 2019
    Date of Event
    October 12, 2019
    Report Date
    November 18, 2019
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    UDI-DI
    4901730020923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 UNABLE TO BE COMPLETED. BASED ON THE DYNAMIC TREND REVIEW NO LOT TREND WAS IDENTIFIED FOR THE REPORTED AES. THIS PRODUCT WAS MANUFACTURED ON OCT 30, 2012.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR BAND AID BRAND SHEER BANDAGES AP 011361AP. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (BAB SHEER 1INX3IN USA 38137004770 ). (B)(4); UPC = (01)4901730020923; EXPIRATION DATE= NA; LOT NUMBER = 121030. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: DRUG: UNKNOWN; DAILY; TO TREAT ARRHYTHMIA; CONSUMER STILL ON DRUG; DRUG: UNKNOWN; DAILY; TO TREAT HYPERTENSION; CONSUMER STILL ON DRUG; DRUG: UNKNOWN; DAILY; TO TREAT HIGH CHOLESTEROL; CONSUMER STILL ON DRUG. 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). 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 (B)(6) YEAR OLD FEMALE CONSUMER REPORTED AN EVENT WITH BAND AID BRAND SHEER BANDAGES. ON (B)(6) 2019, THE CONSUMER APPLIED THE PRODUCT TO A WOUND INSIDE OF HER THIGH AS THE SCAB PEELED OFF AND BLEEDING OCCURRED. WHEN SHE FELT ITCHING SHE REMOVED THE PRODUCT ON (B)(6) 2019, THE APPLICATION SITE HAD A RASH AND A BLISTER APPEARED. THEREAFTER, SHE APPLIED A BANDAGE TO THE WOUND. THE CONSUMER VISITED A DERMATOLOGIST AND RECEIVED UNSPECIFIED TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113090 BAND AID BRAND SHEER BANDAGES ADHESIVE BANDAGE KGX JOHNSON & JOHNSON CONSUMER INC 4901730020923 121030 4901730020923

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention