BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RANGE - ADHESIVE BANDAGES

    MDR report key: 17744653 · Received September 14, 2023

    Report

    Report Number
    2214133-2023-00028
    Event Type
    Injury
    Date Received
    September 14, 2023
    Report Date
    August 23, 2023
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 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. A1, A2, A3, A4, A5: PATIENT IDENTIFIER, PATIENT AGE, GENDER, WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR ONE (1) RANGE - ADHESIVE BANDAGES AP NOT APPLICABLE 0000RGEBABAPD. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (BAND-AID UNSPECIFIED USA NOTAPPLICABLE BABGENUSUNSP BABGENUSUNSP). LOT NUMBER - NI. D4: UDI, UPC, LOT NUMBER AND EXPIRATION DATE ARE NOT AVAILABLE. D10: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: 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. H6: HEALTH EFFECT CLINICAL CODE: E2402 REFERS TO CONSUMER "INTENTIONAL MISUSE/OFF-LABEL USE" OF THE PRODUCT. THIS IS 1 OF 2 MED-WATCHES BEING SUBMITTED AS TWO DEVICES SUCH AS RANGE - ADHESIVE BANDAGES AND BAND AID BRAND KIZU POWER PAD UNSPECIFIED WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2214133-2023-00029 FOR BAND AID BRAND KIZU POWER PAD UNSPECIFIED. 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 · 0

    A CONSUMER REPORTED AN EVENT WITH RANGE ADHESIVE BANDAGE STRIP WHICH WAS APPLIED TO STOP BLEEDING FROM A CUT CAUSED BY A KITCHEN KNIFE. CONSUMER REPORTED THAT THE BLEEDING WAS STOPPED AFTER PRODUCT USE. ON THE NIGHT OF THE SAME DATE, THE CONSUMER REPLACED THE STRIP WITH A SCRATCH POWER PAD. THE NEXT DAY BLEEDING OCCURRED FROM THE WOUND AND DID NOT STOP EASILY. CONSUMER WENT TO THE HOSPITAL AND THE WOUND WAS TREATED AND STITCHED/SEWN UP. THIS IS 1 OF 2 MED-WATCHES BEING SUBMITTED AS TWO DEVICES SUCH AS RANGE - ADHESIVE BANDAGES AND BAND AID BRAND KIZU POWER PAD UNSPECIFIED WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2214133-2023-00029 FOR BAND AID BRAND KIZU POWER PAD UNSPECIFIED. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396900 RANGE - ADHESIVE BANDAGES TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R