BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB VARIETY PACK 30S USA 381370048480

    MDR report key: 8709349 · Received June 18, 2019

    Report

    Report Number
    8041154-2019-00058
    Event Type
    Injury
    Date Received
    June 18, 2019
    Date of Event
    May 19, 2019
    Report Date
    June 18, 2019
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. CONCOMITANT MEDICAL PRODUCTS: CONCOMITANT PRODUCTS: START DATE, FREQUENCY AND LAST USED DATE: SAMLODIPINE 320MG, BESYLATE VALSARTAN 320MG, FOR HIGH BLOOD PRESSURE THE CONSUMER HAS REPORTED A BAB VARIETY PACK 30S USA 381370048480 (LOT 2918B) WHERE THE SPECIFIC BAB THAT WAS USED IS UNKNOWN. BELOW IS THE LIST OF ALL POSSIBLE PRODUCTS IN THE VARIETY PACK. BABAB 5/8" CUSHION-CARE SPORT STRIP (FOAM) BABAB 1" CLEAR WATERBLOCK BABAB 1" TOUGH STRIP (HEAVY DUTY) 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. ETHNICITY: PATIENT ETHNICITY AND RACE WAS NOT PROVIDED FOR REPORTING. UPC #: (B)(4), LOT #: 2918B, UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION CONCOMITANT PRODUCTS: START DATE, FREQUENCY AND LAST USED DATE: METOPROLOL 50MG DAILY, FOR BLOOD PRESSURE. RANITIDINE 150 MG, FOR REFLUX. DICYCLOMINE 10MG DAILY, FOR IRRITABLE BOWEL. HYDROCHLOROTHIAZIDE 25 MG, FOR HIGH BLOOD PRESSURE. AMLODIPINE & VALSARTAN 320MG, FOR HIGH BLOOD PRESSURE. SENTOL LOTION. PLUS DAILY B12 AND VITAMINE E. DEVICE EVALUATED BY MFR, MANUFACTURE DATE: 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. MANUFACTURING DATE IS 10/18/2018. (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 CARETAKER REPORTED AN EVENT WITH AN UNKNOWN BAND-AID FROM BAB VARIETY PACK 30S. THE CARETAKER ALLEGES THAT THE SKIN WAS REMOVED FROM HER MOTHER'S LEG AND CAUSED SEVERE TRAUMA. THE CONSUMER¿S SKIN RIPPED OFF WITH A LACERATION AND THE PRODUCT WAS VERY HARD TO PULL OFF OF THE SKIN, WHICH WAS PAINFUL. IT WAS BLEEDING PROFUSELY TO THE POINT THAT IT WOULD NOT STOP. THE CONSUMER SOUGHT MEDICAL TREATMENT. A VISITING NURSE CAME ON AN EMERGENCY VISIT AND WRAPPED AND ELEVATED THE LEG. A FEW DAYS LATER, A SPECIALIST EXAMINED THE AREA OF TRAUMA, NUMBED IT AND APPLIED LARGER, OCCLUSIVE, MEDICATED BANDAGES. THE DOCTOR RECOMMENDED USING THE GIVEN BANDAGES, KEEPING THE AREA COVERED AND PERFORM A FOLLOW UP VISIT. THE CONSUMER HAS NOT RECOVERED FROM THE SYMPTOMS AND THE AREA IS STILL IRRITATED, RED AND BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502731 BAB VARIETY PACK 30S USA 381370048480 ADHESIVE BANDAGES KGX JOHNSON & JOHNSON CONSUMER INC 381370048480 2918B

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention AMLODIPINE VALSARTAN| BESYLATE VALSARTAN| DICYCLOMINE| HYDROCHLOROTHIAZIDE| METOPOROLO| RANITIDINE| SAMLODIPINE| SENTOL LOTION