BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES

    MDR report key: 16146678 · Received January 12, 2023

    Report

    Report Number
    2214133-2023-00002
    Event Type
    Injury
    Date Received
    January 12, 2023
    Date of Event
    December 17, 2022
    Report Date
    January 12, 2023
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    NAD
    UDI-DI
    4901730021913
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. H4, H6: 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 JANUARY 22,2022. 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 · 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 AND 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. PATIENT IDENTIFIER, WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR (BAND AID BRAND KIZU POWER PAD (KPP) LARGE 6CT AP 4901730021913 4901730021913APB 4901730021913APB). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (BAND AID BRAND HYDROSEAL BANDAGES ALL PURPOSE 1CT USA 381371175338 8137117533USA 8137117533USA). UDI#(B)(4), UPC: 4901730021913, EXPIRATION DATE - 12/21/2024, LOT NUMBER: 0552C. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. (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 · 0

    ON (B)(6) 2022, A 75-YEAR-OLD FEMALE CONSUMER GOT A CUT WOUND ON HER LEFT FINGER. SHE PURCHASED BAND AID BRAND KIZU POWER PAD (KPP) LARGE AT A NEARBY DRUG STORE AND USED IT FOR THE FIRST TIME. ON (B)(6) 2022, SHE FELT AN INDESCRIBABLE FEAR AND HAD POOR PHYSICAL CONDITION, BECAUSE OF WHICH SHE COULD NOT HELP LYING DOWN. ON (B)(6) 2022, THE SYMPTOM RESOLVED. HOWEVER, SHE WAS WORRIED ABOUT IT AND VISITED A HOSPITAL ON (B)(6) 2022. AT THE HOSPITAL, KPP WAS REMOVED, AND SHE HAD HER WOUND TREATED WITH UNKNOWN TREATMENT, BUT THE CAUSE OF THE SYMPTOM WAS UNKNOWN. SINCE SHE HAD BEEN APPLYING KPP FOR A LONG TIME, SHE THOUGHT THAT SOMETHING MIGHT HAVE BEEN ABSORBED THROUGH HER SKIN, AND A SIDE EFFECT OR SOMETHING LIKE THAT MIGHT HAVE OCCURRED. THE CONSUMER IS NO LONGER EXPERIENCING ANY SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438131 BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES DRESSING, WOUND, OCCLUSIVE NAD JOHNSON & JOHNSON CONSUMER INC 4901730021913 0552C 4901730021913

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention