BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND-AID WATERBLOCK STRIPS 10 NEW AP

    MDR report key: 10678511 · Received October 14, 2020

    Report

    Report Number
    1000599868-2020-00012
    Event Type
    Injury
    Date Received
    October 14, 2020
    Date of Event
    March 12, 2020
    Report Date
    October 15, 2020
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 - PRODUCT NAME; D4 - UPC; UDI - (B)(4). BASED ON THE UPDATED PRODUCT INFORMATION RECEIVED FROM J&J SHANGHAI THE MANUFACTURING SITE. THE REPORTED LOT NUMBER 200403 CORRESPONDS TO BAND-AID WATERBLOCK STRIPS 10 NEW AP 6916999000737 0038101164APA 0038101164APA. BASED ON THIS INFORMATION, THIS PRODUCT DOES NOT MEET THE SAME/SIMILAR REPORTING CRITERIA. THEREFORE, THE INITIAL EMDR WILL NO LONGER BE CONSIDERED AS REPORTABLE COMPLAINT. THIS IS 2 OF 2 FOLLOW-UP MED-WATCHES BEING SUBMITTED AS TWO DEVICES (BAND-AID WATERBLOCK 5CT AND BAND-AID WATERBLOCK 10CT) WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 1000599868-2020-00011. 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.

    Description of Event or Problem · 0

    THIS IS 2 OF 2 FOLLOW-UP MED-WATCHES BEING SUBMITTED AS TWO DEVICES (BAND-AID WATERBLOCK 5CT AND BAND-AID WATERBLOCK 10CT) WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 1000599868-2020-00011. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WEIGHT AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR (RANGE - ADHESIVE BANDAGES AP NOT APPLICABLE (B)(4)). UPC #, AND UDI # IS NOT AVAILABLE. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (BAND-AID UNSPECIFIED USA BABGENUS). 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 BABGENUS). 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). THIS IS 2 OF 2 MED-WATCHES BEING SUBMITTED AS TWO DEVICES (BAND-AID WATERBLOCK 5CT AND BAND-AID WATERBLOCK 10CT) WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 1000599868-2020-00011. 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 · 1

    IT WAS REPORTED THE PATIENT BOUGHT A BOX OF WATERPROOF BAND-AID DUE TO FINGER LACERATION AND BLEEDING, AND USED IT IMMEDIATELY AFTER RETURNING HOME. THE NEXT DAY, THE PATIENT REPORTED SKIN ALLERGY AFTER APPLYING THE BAND-AID, AND THE SKIN WAS RED AND ITCHY WHERE THE ADHESIVE TAPE WAS APPLIED. THE CUSTOMER WAS GIVEN WOUND CLEANING TREATMENT AT THE SCENE, AND WAS GIVEN ANTI-ALLERGIC DRUGS ON THE RED ITCHING AND OTHER ALLERGIC SKIN; THEN RETURNED ON THE SAME DAY, IT WAS REPORTED THAT THE SYMPTOMS DISAPPEARED. THIS IS 2 OF 2 MED-WATCHES BEING SUBMITTED AS TWO DEVICES (BAND-AID WATERBLOCK 5CT AND BAND-AID WATERBLOCK 10CT) WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 1000599868-2020-00011. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143226 BAND-AID WATERBLOCK STRIPS 10 NEW AP TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC 6916999000737 200403

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention