BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB SHEER BANDAGES

    MDR report key: 8701046 · Received June 14, 2019

    Report

    Report Number
    8041154-2019-00057
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    May 18, 2019
    Report Date
    July 2, 2019
    Manufacturer
    JOHNSON AND JOHNSON CONSUMER INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. CORRECTED DATA: RESULTS & CONCLUSIONS EVALUATION CODES: DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR BAB SHEER LARGE 10CT USA WITH UPC # (B)(4), LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: DRUG: BETA BLOCKER; DAILY; TO TREAT HEART ISSUE; CONSUMER STILL ON DRUG. DRUG: CYMBALTA; DAILY; TO TREAT UNKNOWN ISSUE; CONSUMER STILL ON DRUG. DRUG: OMEPRIZAL; DAILY; TO TREAT UNKNOWN ISSUE; CONSUMER STILL ON DRUG. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. (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, (B)(6) POUND FEMALE CONSUMER REPORTED AN EVENT WITH BAB SHEER LARGE. THE CONSUMER REPORTED THAT AFTER USE OF THE PRODUCT WHEN REMOVING THE BANDAGE REMOVED HER FLESH WHERE THE ADHESIVE WAS TOUCHING HER SKIN. THE CONSUMER SOUGHT MEDICAL ATTENTION FROM HER HEALTH CARE PROFESSIONAL (HCP). HER HCP PRESCRIBED AN UNKNOWN ANTIBIOTIC CREAM, APPLIED GAUZE AND SENSITIVE SKIN TAPE. THE CONSUMER IS STILL EXPERIENCING SYMPTOMS OF BLISTERS AND SCABBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493840 BAB SHEER BANDAGES ADHESIVE BANDAGE KGX JOHNSON AND JOHNSON CONSUMER INC. 381370047681

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention BETA BLOCKER| CYMBALTA| OMEPRIZAL| BETA BLOCKER| CYMBALTA| OMEPRIZAL