BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J&J BAND AID BRAND FIRST AID HURT FREE NON STICK PADS

    MDR report key: 14799602 · Received June 24, 2022

    Report

    Report Number
    2214133-2022-00030
    Event Type
    Injury
    Date Received
    June 24, 2022
    Date of Event
    February 8, 2022
    Report Date
    May 31, 2022
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    NAB
    UDI-DI
    381371161430
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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. PATIENT WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. BRAND NAME, COMMON DEVICE NAME, MANUFACTURE NAME, CITY AND STATE, LOT #: THIS REPORT IS FOR ONE (1) J&J BAND-AID BRAND FIRST AID HURT FREE NON STICK PADS 3 X 4 10CT USA 381371161430 381371161430USA, 381371161430USA, LOT NUMBER-1821A. THE LOT NUMBER 1821A WAS INVALID . UDI #: (B)(4). UPC # 381371161430. LOT NUMBER - NI. EXPIRATION DATE - NA. DEVICE AVAILABLE FOR EVALUATION: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATED BY MFR AND MANUFACTURE DATE: DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. THE LOT NUMBER 1821A WAS INVALID THEREFORE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT A VALID LOT NUMBER. (B)(4). THIS IS FOR NON-STICK PADS. SEE MEDWATCHES 2214133-2022-00028 & 2214133-2022-00029 FOR GAUZE PADS. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. THIS IS 1 OF 2 MED-WATCHES BEING SUBMITTED FOR NON-STICK PADS AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2214133-2022-00031. 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

    CONSUMER REPORTED APPLYING J&J BAND-AID BRAND FIRST AID HURT FREE NON STICK PADS FOR HIS SMALL BRUISE AND BURN ON HIS LEGS ON (B)(6) 2022. AS PER THE CONSUMER, ON (B)(6) 2022 THE J&J BAND AID BRAND FIRST AID CUSHION CARE GAUZE PADS, THE BAND-AID BRAND FIRST AID HURT FREE NON STICK PADS AND THE TOPICAL TREATMENT THAT HE USED CAUSED MORE SWELLING AND INFECTED IT MORE. THE CONSUMER ALSO REPORTED, INFLAMMATION WAS PRE-EXISTING CONDITION AND THE PRODUCT WORSENED THAT CONDITION AND THE INITIAL BURN. CONSUMER STOPPED USING THE PRODUCT AND THEN DRANK AN ORAL ANTIBIOTIC THAT HIS DOCTOR PRESCRIBED. THE GAUZE AND PADS WERE APPLIED TWICE A DAY. THIS IS FOR NON-STICK PADS. SEE MEDWATCHES 2214133-2022-00028 & 2214133-2022-00029 FOR GAUZE PADS. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. THIS IS 1 OF 2 MED-WATCHES BEING SUBMITTED FOR NON-STICK PADS AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2214133-2022-00031. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256784 J&J BAND AID BRAND FIRST AID HURT FREE NON STICK PADS GAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE NAB JOHNSON & JOHNSON CONSUMER INC 381371161430 1821A 381371161430

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Required Intervention NEOSPORIN (TOPICAL)