BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADHESIVE BANDAGES

    MDR report key: 20967435 · Received December 18, 2024

    Report

    Report Number
    2214133-2024-00041
    Event Type
    Injury
    Date Received
    December 18, 2024
    Date of Event
    November 27, 2024
    Report Date
    December 18, 2024
    Manufacturer
    KENVUE
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    KENVUE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH KENVUE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, KENVUE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AND ADMISSION THAT THE DEVICE, KENVUE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. D4: MODEL #S: 6916999215216 AND 6916999000737. H2, H4, H6: THERE ARE TWO UPCS 6916999215216 AND 6916999000737 MANUFACTURED UNDER THE REPORTED LOT NUMBER 240328. THE TWO UPCS ACCOUNT FOR SAME PRODUCT IN DIFFERENT QUANTITIES 5 COUNT & A 10 COUNT. DEVICE HISTORY RECORDS REVIEW FOR BOTH UPCS WERE 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 MAR-28-2024. 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

    KENVUE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH KENVUE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, KENVUE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AND ADMISSION THAT THE DEVICE, KENVUE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A6: PATIENT IDENTIFIER, WEIGHT, ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D4: THIS REPORT IS FOR ONE (1) BAND AID BRAND UNSPECIFIED AP NOTAPPLICABLE 0000RGEBABAPD. LOT NUMBER - NI. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (BAND-AID UNSPECIFIED USA NOTAPPLICABLE BABGENUSUNSP BABGENUSUNSP). D4: 510(K) EXEMPT DEVICE I COMPLAINT. D9: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H6: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED AT THIS TIME; NO CONCLUSION, AT THIS TIME, COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. H6: HEALTH EFFECT CLINICAL CODES: E2402 ¿ REFERS TO HYPERSENSITIVITY/ALLERGIC REACTION INCLUDING DEVELOPED RED RASH, SWELLING AND PRURITUS AT THE APPLICATION SITE FOLLOWING USE OF PRODUCT. F11- REFERS TO MINOR INJURY/ ILLNESS / IMPAIRMENT. 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

    AN EVENT WAS REPORTED WITH UNSPECIFIED BAND AID BRAND BANDAGE. A 58 YEAR OLD MALE CONSUMER ACCIDENTALLY FELL ON (B)(6) 2024. THE CONSUMER BROKE THE SKIN AT THE RIGHT ANKLE, WITH MILD BLEEDING, AND WENT TO THE HOSPITAL FOR EXAMINATION WITHOUT SERIOUS PROBLEMS, SO THE PATIENT BOUGHT IODOPHOR, COTTON SWAB AND THE BANDAGE IN THE DRUGSTORE AND THE CONSUMER WENT BACK HOME DISINFECTED THE WOUND HIMSELF. IT WAS ALLEGED THAT THE BANDAGE APPLICATION TIME WAS TOO LONG, IT WAS NOT TORN OFF IN 12 HOURS, RESULTING IN REDNESS, SWELLING AND PRURITUS AT THE APPLICATION SITE. ON (B)(6) 2024, THE PATIENT CAME TO THE DRUGSTORE TO CONSULT THE PHARMACIST WHETHER THE BANDAGE CAUSED ALLERGY. IMMEDIATELY, THE PHARMACIST PRESCRIBED A BOX OF ERYTHROMYCIN OINTMENT AND THE PATIENT APPLIED IT AT HOME. THE NEXT MORNING, IT WAS RECOVERING, WITHOUT PRURITUS, AND THE REDNESS AND SWELLING SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2283533 ADHESIVE BANDAGES TAPE AND BANDAGE, ADHESIVE KGX KENVUE NOTAPPLICABLE 240328

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention