BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID TOUGH STRIP WATERPROOF BANDAGES

    MDR report key: 11267257 · Received February 2, 2021

    Report

    Report Number
    8041154-2021-00003
    Event Type
    Injury
    Date Received
    February 2, 2021
    Date of Event
    January 8, 2021
    Report Date
    June 28, 2021
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. CORRECTION: SECTION A. PATIENT INFORMATION. A2- AGE AT TIME OF EVENT: 74 YEARS. ADDITIONAL INFORMATION: B5: A LETTER WAS RECEIVED FROM CONSUMER ON JUNE 28, 2021. THE CONSUMER REPORTED WOUND HAS RESOLVED. CONSUMER ALSO UPDATED HIS AGE TO 74. THIS IS 1 OF 2 FOLLOW-UP MED-WATCHES BEING SUBMITTED AS SAME PATIENT WERE INVOLVED IN THIS EVENT FOR SAME PRODUCT. SEE MEDWATCH 8041154-2021-00004. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #1 MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    A LETTER WAS RECEIVED FROM CONSUMER ON JUNE 28, 2021. THE CONSUMER REPORTED WOUND HAS RESOLVED. CONSUMER ALSO UPDATED HIS AGE TO 74. THIS IS 1 OF 2 FOLLOW-UP MED-WATCHES BEING SUBMITTED AS SAME PATIENT WERE INVOLVED IN THIS EVENT FOR SAME PRODUCT. SEE MEDWATCH 8041154-2021-00004. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WEIGHT AND ETHNICITY WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR (BAND-AID TOUGH STRIP WATERPROOF XL 10S CAN 62600062222 6260006222CAA). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (BAB TOUGH STRIPS WATERPROOF EX LG 10S USA 381370055662 8137005566USA). UDI: (B)(4), UPC-62600062222, EXPIRATION DATE-NA, LOT NUMBER-NI. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (BAB TOUGH STRIPS WATERPROOF EX LG 10S USA 381370055662 8137005566USA). 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 1 OF 2 MED-WATCHES BEING SUBMITTED AS SAME PATIENT WERE INVOLVED IN THIS EVENT FOR SAME PRODUCT. SEE MEDWATCH 8041154-2021-00004. 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

    THIS INCIDENT INVOLVED A (B)(6)-YEAR-OLD MALE CONSUMER USING BAND-AID® BRAND TOUGH-STRIPS® WATERPROOF EXTRA LARGE ADHESIVE BANDAGES (10 COUNT) (LOT NOT REPORTED). NO DETAILS ABOUT CONSUMER¿S MEDICAL HISTORY, CONCOMITANT MEDICATIONS, HEIGHT OR WEIGHT WERE REPORTED. ON (B)(6) 2021, THE CONSUMER APPLIED A BANDAGE TO COVER AN INCH AND A HALF CUT ON THE BACK OF HIS LEFT HAND. AFTER A FEW HOURS, WHILE THE CONSUMER WAS REMOVING IT, THE BANDAGE TORE HIS SKIN OFF IN TWO PLACES WHERE THE ADHESIVE WAS AND CAUSED SOME BLEEDING. THE CONSUMER APPLIED THE SECOND BANDAGE. WHILE REMOVING THE SECOND BANDAGE TWO HOURS LATER, THE BANDAGE REMOVED A BIGGER PIECE OF HIS SKIN, ABOUT A SQUARE INCH. HIS HAND LOOKED ¿RAW¿ AND THERE WAS A SIGNIFICANT AMOUNT OF BLEEDING. THE CONSUMER DISCONTINUED USING THE BANDAGES. THE CONSUMER¿S DAUGHTER, WHO IS A NURSE, APPLIED 2 HYDROCOLLOID PADS TO HIS WOUND. OVERNIGHT, THE WOUND WAS BLEEDING SIGNIFICANTLY AND IT STAINED THROUGH THE DRESSING. ON (B)(6) 2021, THE NURSE USED MEPORE AND JELONET DRESSINGS AS WELL AS UNSPECIFIED BANDAGES ON THE CONSUMER¿S WOUND. THE CONSUMER WAS VERY CONCERNED ABOUT HIS HAND SINCE IT WAS THE FIRST TIME HE EXPERIENCED SUCH AN INCIDENT. HE WAS CONSIDERING GOING TO THE HOSPITAL EMERGENCY BUT WAS ADVISED AGAINST IT TO AVOID CONTACT WITH OTHER SICK PATIENTS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER ON 26-JAN-2021. THE NURSE WAS CHANGING THE DRESSINGS EVERY NIGHT FROM (B)(6) 2021 TO (B)(6) 2021. ADDITIONAL TREATMENT INCLUDED NEXCARE PRODUCTS, UNSPECIFIED POLYSPORIN, SALINE SOLUTION, AND DIABETIC LIGHT BANDAGES. THE CONSUMER¿S SECOND DAUGHTER, WHO IS A FAMILY PHYSICIAN, TREATED HIS WOUND ON (B)(6) 2021. IN THE MORNING OF (B)(6) 2021, SHE RECOMMENDED NOT TO COVER THE WOUND WITH ANY MORE DRESSINGS. SHE CHECKED THE WOUND AGAIN ON (B)(6) 2021. THE CONSUMER REPORTED HE DID NOT COVER THE WOUND SINCE (B)(6) 2021 BUT HIS HAND WAS STILL NOT HEALED AND HE WAS NOT ABLE TO FULLY USE IT. THIS IS 1 OF 2 MED-WATCHES BEING SUBMITTED AS SAME PATIENT WERE INVOLVED IN THIS EVENT FOR SAME PRODUCT. SEE MEDWATCH 8041154-2021-00004. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161412 BAND AID TOUGH STRIP WATERPROOF BANDAGES TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC 62600062222

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention