BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES

    MDR report key: 19287586 · Received May 10, 2024

    Report

    Report Number
    2214133-2024-00019
    Event Type
    Injury
    Date Received
    May 10, 2024
    Report Date
    April 24, 2024
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC.
    Product Code
    NAD
    UDI-DI
    4901730021913
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    JOHNSON & AMP; 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 & AMP; 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, AGE AT TIME OF EVENT, GENDER, 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 4901730021913 APB 4901730021913 APB. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA BAND AID BRAND HYDROSEAL BANDAGES ALL PURPOSE 1 CT USA 381371175338 8137117533USA 8137117533USA. LOT NUMBER WAS NOT AVAILABLE FOR REPORTING. UPC: 4901730021913 LOT #: NI UDI #: (B)(4). 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. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. HEALTH EFFECT CLINICAL CODE: E040203 ALSO REFERS TO CONSUMER ALLEGED ABOUT "WOUND SMELLED ROTTEN". E2330 ALSO REFERS TO CONSUMER ALLEGED ABOUT "PAIN IN ANKLE &Q UOT;. E2402 REFERS TO CONSUMER "INTENTIONAL MISUSE/OFF-LABEL USE & QUOT; OF THE PRODUCT. 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

    CONSUMER REPORTED HE/SHE STEPPED ON A NAIL WITH HIS/HER HEEL, AND A WOUND DEVELOPED. HE/SHE HAD HIS/HER WOUND SUTURED AT A HOSPITAL. ONE MONTH LATER, HE/SHE HAD HIS/HER STITCHES REMOVED, BUT THE WOUND POORLY HEALED AND WAS GOUGED OUT. AFTER THAT, HE/SHE APPLIED THE PRODUCT FOR MORE THAN A MONTH AND A HALF ON HIS/HER DOCTOR & APOS;S RECOMMENDATION. DURING THAT TIME, HE/SHE SAW THE DOCTOR EVERY WEEK FOR CONSULTATIONS AND WAS ALWAYS TOLD TO USE THE PRODUCT. THE WOUND SMELLED ROTTEN, AND HE/SHE HAD PAIN ON HIS/HER ANKLE, NOT ON HIS/HER HEEL WHERE THE WOUND HAD DEVELOPED, AND SO HE/SHE COULD NOT SLEEP. HE/SHE REQUESTED TO THE HOSPITAL TO REFER HIM/HER TO ANOTHER DOCTOR BECAUSE THERE WAS NOTHING HE/SHE COULD DO ABOUT IT AND HE/SHE WANTED TO CURE THE WOUND IMMEDIATELY. ON THE PREVIOUS DAY OF THIS REPORTING (23-APR-2024), HE/SHE VISITED ANOTHER HOSPITAL. A DOCTOR OF THE HOSPITAL INSTRUCTED HIM/HER TO STOP USING THE PRODUCT AND APPLY A TOPICAL MEDICINE. THEREFORE, HE/SHE STOPPED USING THE PRODUCT ON THE PREVIOUS DAY OF THIS REPORTING. HE/SHE ASKED CCC WHY THE EVENTS HAD OCCURRED. HE/SHE STATED THAT THE DOCTOR WHOM HE/SHE SAW AT FIRST HAD MISJUDGED HOW TO TREAT THE WOUND. IT WAS ALSO REPORTED THAT, THE SYMPTOMS HAVE STAYED THE SAME AFTER THE PATIENT STOPPED USING THE PRODUCT. NO FURTHER INFORMATION WAS PROVIDED ABOUT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905168 BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES DRESSING, WOUND, OCCLUSIVE NAD JOHNSON & JOHNSON CONSUMER INC. 4901730021913 4901730021913

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention