BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND-AID CLEAR STRIPS 10 AP

    MDR report key: 9877837 · Received March 25, 2020

    Report

    Report Number
    2214133-2020-00013
    Event Type
    Injury
    Date Received
    March 25, 2020
    Date of Event
    February 1, 2020
    Report Date
    April 1, 2020
    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 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. CORRECTED DATA: D1 D4 UPC: 4901730075558, LOT NUMBER: 180305C UDI: (B)(4). G1,2 D1, D2, D3, D4: THIS REPORT IS FOR (BAND-AID CLEAR STRIPS 10 AP 4901730075558 3730211102APA). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SAME SIMILAR DEVICE MARKETED IN THE USA (BAB PERFECT BLEND CLEAR LIGHT ASST 45S USA 381370057017 8137005701USD). 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 MARCH 5, 2018. THIS IS 2 OF 2 FOLLOW-UP MED-WATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2214133-2020-00012. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. 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. WEIGHT, ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR (RANGE - ADHESIVE BANDAGES AP NOT APPLICABLE 0000RGEBABAPD 0000RGEBABAPD). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SAME SIMILAR DEVICE MARKETED IN THE USA (BAND-AID UNSPECIFIED USA, CLEAR 10S). UDI: (B)(4), UPC = NI, EXPIRATION DATE= NA, LOT NUMBER = 180305C. 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 (BAND-AID UNSPECIFIED USA, CLEAR 10S). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. (B)(4). THIS IS 2 OF 2 MED-WATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2214133-2020-00012. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    CONSUMER (FATHER) APPLIED BAND-AID TO HIS (B)(6) YEAR OLD DAUGHTER TO COVER A BUG BIT. THE CONSUMER STATED THE AREA WHERE THE PAD WAS BECAME INFLAMED AND WAS PAINFUL. CONSUMER REMOVED THE BANDAGE FROM HIS DAUGHTER AND STATED THE APPLICATION SITE OF PAD WAS RUPTURED. THE CONSUMER (FATHER) TOOK HIS DAUGHTER TO THE HOSPITAL AND SHE WAS PRESCRIBED AN UNKNOWN OINTMENT. CONSUMER STATED THE INSECT BITE BECAME A SCAB AND IS RESOLVING. THIS IS 2 OF 2 MED-WATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2214133-2020-00012. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342205 BAND-AID CLEAR STRIPS 10 AP TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC. 4901730075558 180305C

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention