BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB CLEAR WATER BLOCK PLUS 30S USA 381370056591

    MDR report key: 8832768 · Received July 26, 2019

    Report

    Report Number
    8041154-2019-00067
    Event Type
    Injury
    Date Received
    July 26, 2019
    Report Date
    July 1, 2019
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UDI: (B)(4). DEVICE AVAILABLE FOR EVALUATION: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: CONSUMER STILL ON DRUGS FOR FOLLOWING CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: GABAPENTIN 300MG 3X PER DAY. FLOMAX. PRAZOSIN 4MG. PROPRANOLOL 10MG 3X PER DAY. KCL 10MEQ 2 TABLETS 2X PER DAY. FUROSEMIDE. PRAVASTATIN. FAMOTIDINE PRN. OMEPRAZOLE 20MG 1X PER DAY. BACLOFEN 10MG 3XPER DAY. ALBUTEROL. ATENOLOL 100 2X PER DAY. ALLOPURINOL. MAGNESIUM 500MG 2X PER DAY. METFORMIN 500MG 2 TABS QD AT SUPPER. IMDUR. NITROGYLCERIN SL. ZONISAMIDE 50MG. MELATONIN. ASA 81 1X PER DAY. NIFEDIPINE 2X PER DAY. MTV 1X PER DAY. IRON. DEVICE EVALUATED BY MFR, MANUFACTURE DATE: 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). THIS IS TWO OF TWO MEDWATCHES BEING SUBMITTED AS CONSUMER REPORTED ADVERSE EVENTS FOR BOTH LEFT AND RIGHT FOOT. SEE MEDWATCH 8041154-2019-00067 (LEFT FOOT) AND 8041154-2019-00068 (RIGHT FOOT). THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. 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

    CONSUMER REPORTED 1/4" OF THE SKIN WAS REMOVED FROM HIS LEFT TOE FOOT AFTER APPLYING BAB CLEAR WATER BLOCK PLUS. ADDITIONALLY CONSUMER REPORTED THE HOLE IT LEFT WAS 3/4" WIDE NOW X 2 1/4" FROM WHEN THE BAND-AID PULLED OFF THE SKIN AND WAS WRAPPED IN GAUZE. CONSUMER SOUGHT MEDICAL ATTENTION FROM HEALTH CARE PROVIDER AND WAS PRESCRIBED MEDICATION. THE SYMPTOMS HAVE NOT RESOLVED. THIS IS TWO OF TWO MEDWATCHES BEING SUBMITTED AS CONSUMER REPORTED ADVERSE EVENTS FOR BOTH LEFT AND RIGHT FOOT. SEE MEDWATCH 8041154-2019-00067 (LEFT FOOT) AND 8041154-2019-00068 (RIGHT FOOT). THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625077 BAB CLEAR WATER BLOCK PLUS 30S USA 381370056591 ADHESIVE BANDAGE KGX JOHNSON & JOHNSON CONSUMER INC 381370056591

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention