BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND KPP BANDAGES

    MDR report key: 10489228 · Received September 3, 2020

    Report

    Report Number
    2214133-2020-00033
    Event Type
    Injury
    Date Received
    September 3, 2020
    Date of Event
    August 23, 2020
    Report Date
    September 28, 2020
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    NAD
    UDI-DI
    4901730077699
    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 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. CORRECTIVE DATA: EXPIRATION DATE: 12/31/2022. UDI #: (B)(4). 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. THIS PRODUCT WAS MANUFACTURED ON JANUARY 24, 2020. H6: HEALTH IMPACT - 4613. 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 · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT WEIGHT AND ETHNICITY WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR (BAND AID BRAND KPP SPOT 10S 2015 AP 4901730077699 0037131789APA). 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). UPC #: (B)(4), LOT #: 0240C, EXPIRATION DATE: NA, UDI #: (B)(4). 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. 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 · 1

    A MOTHER REPORTED AN EVENT WITH BAND AID BRAND KPP BANDAGE. A MOTHER (REPORTER) OF A (B)(6) OLD GIRL (CONSUMER) REPORTED THAT ON (B)(6) 2020, THE CONSUMER GOT A WOUND WHOSE SIZE WAS ABOUT 8MM. ON (B)(6) 2020, THE REPORTER APPLIED KPP TO THE CONSUMER¿S WOUND. ON (B)(6) 2020, REDNESS, BUMPS, AND ITCHING OCCURRED ON THE WOUND. ON THE (B)(6) 2020, THE REPORTER TOOK THE CONSUMER TO A HOSPITAL AFTER REMOVING THE KPP. ACCORDING TO THE REPORTER, SHE WAS TOLD BY A PHYSICIAN THAT INFLAMMATION OCCURRED ON THE CONSUMER¿S WOUND AND RECEIVED A PRESCRIPTION OF AN OINTMENT. AFTER THE REPORTER APPLIED THE OINTMENT TO THE CONSUMER¿S WOUND, IT SEEMED THAT THE BUMPS SPREAD TO THE CONSUMER¿S CHEEK. THE REPORTER STATED THAT THE AREA OF THE BUMPS WAS ABOUT 2 X 2.5 CM AND IS STILL EXPERIENCING SYMPTOMS OF THE RASH. CONSUMER WAS PRESCRIBED DRUG: RINDERON VG (BETAMETHASONE VALERATE GENTAMICIN SULFATE), TWICE A DAY, IN THE MORNING AND THE NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956335 BAND AID BRAND KPP BANDAGES DRESSING, WOUND, OCCLUSIVE NAD JOHNSON & JOHNSON CONSUMER INC 4901730077699 0240C 4901730077699

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization| R