BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J&J BAND AID BRAND CUSHION CARE SPORTS STRIP

    MDR report key: 14393725 · Received May 13, 2022

    Report

    Report Number
    8041154-2022-00006
    Event Type
    Injury
    Date Received
    May 13, 2022
    Date of Event
    April 17, 2022
    Report Date
    May 24, 2022
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    UDI-DI
    381370047230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FOR ONE (1) J&J BAND AID BRAND CUSHION CARE SPORTS STRIP 30CT USA 381370047230 381370047230USA 381370047230USA, LOT NUMBER 3071B. UDI #: (B)(4), UPC #: 381370047230 , LOT #: 3071B, EXP: NA, DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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.

    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. 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 NOVEMBER 3, 2021. 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

    A FEMALE CONSUMER REPORTED AN EVENT WITH J&J BAND AID BRAND CUSHION CARE SPORTS STRIP. THE CONSUMER REPORTED SHE PUT A BAND-AID CUSHION CARE STRIP ON TO PROTECT HER INCISION, BUT IT MADE IT WORSE. THE CONSUMER STATED THAT THE PRODUCT IRRITATED HER, SHE HAD RED BLOTCHY STUFF ALL OVER THE PLACE WHERE SHE APPLIED THE BAND-AID. SHE HAD AN ALLERGIC REACTION. THE CONSUMER ALLEGED THAT SHE HAD GLUE LEFT ON HER INCISION DUE TO THE PRODUCT BEING HARD TO REMOVE. THE CONSUMER SOUGHT MEDICAL TREATMENT AND WAS PRESCRIBED AN UNKNOWN STEROID CREAM FOR TREATMENT. THE SYMPTOMS HAVE IMPROVED BUT THE CONSUMER IS STILL EXPERIENCING THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2042500 J&J BAND AID BRAND CUSHION CARE SPORTS STRIP TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC 381370047230 3071B 381370047230

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention