BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB FLEXIBLE FABRIC 3/4IN 30S USA 381370044314 8137004431USA

    MDR report key: 8695406 · Received June 13, 2019

    Report

    Report Number
    8041154-2019-00055
    Event Type
    Injury
    Date Received
    June 13, 2019
    Report Date
    June 21, 2019
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: DATE OF BIRTH: (B)(6)1937. 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 (B)(6)2019. 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. (B)(4). EXPIRATION DATE = NA. LOT NUMBER = 0309B. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: DRUG: UNKNOWN BLOOD THINNER MEDICATION; DAILY. DRUG: UNKNOWN SEIZURE MEDICATION; DAILY. DRUG: UNKNOWN ANXIETY MEDICATION; DAILY . 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. 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 FEMALE CONSUMER REPORTED AN EVENT WITH BAB FLEXIBLE FABRIC BANDAGE. THE CONSUMER REPORTED SHE USED FLEXIBLE FABRIC BAND-AID AND WHEN SHE REMOVED THE BANDAGE, IT RIPPED HER SKIN OFF. THE CONSUMER SOUGHT MEDICAL TREATMENT AT THE HOSPITAL. A HEALTH CARE PROFESSIONAL (HCP) TREATED THE EVENT BY PROVIDING A TETANUS SHOT AND RE-BANDAGED THE WOUND. THE PATIENT IS STILL EXPERIENCING THE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489472 BAB FLEXIBLE FABRIC 3/4IN 30S USA 381370044314 8137004431USA ADHESIVE BANDAGES KGX JOHNSON & JOHNSON CONSUMER INC 381370044314 0309B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN ANXIETY MEDICATION| UNKNOWN BLOOD THINNER MEDICATION| UNKNOWN SEIZURE MEDICATION| UNKNOWN ANXIETY MEDICATION| UNKNOWN BLOOD THINNER MEDICATION| UNKNOWN SEIZURE MEDICATION