BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND TRU STAY SHEER BANDAGES / SHEER

    MDR report key: 17840428 · Received September 28, 2023

    Report

    Report Number
    8041154-2023-00024
    Event Type
    Injury
    Date Received
    September 28, 2023
    Date of Event
    August 20, 2023
    Report Date
    September 5, 2023
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    UDI-DI
    381370046691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 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. A1, A2, A3, A4, A5: PATIENT IDENTIFIER, PATIENT AGE, GENDER, WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. B2: THIS EVENT WILL BE CATEGORIZED AS A SERIOUS INJURY- OTHER SERIOUS OR IMPORTANT MEDICAL EVENT. ALTHOUGH THE CONSUMER CHECKED OFF ¿OUTCOMES ATTRIBUTED TO ADVERSE EVENT: REQUIRED INTERVENTION, OTHER SERIOUS OR IMPORTANT MEDICAL EVENT, LIFE THREATENIN¿ ON MW5144875, SCANT INFORMATION IS AVAILABLE TO PROVIDE A MORE MEANINGFUL ASSESSMENT OF THE CASE, SUCH AS THE TIME TO ONSET OF THE EVENTS AND PRODUCT USE IS NOT CLEAR TO ESTABLISH A TEMPORAL RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT; NATURE OF THE INJURY; FURTHERMORE THERE ARE NO DETAILS ON THE MEDICAL HISTORY, PROGRESSION OF THE CONDITION, RESULTS OF MEDICAL CONSULTATIONS OR DIAGNOSTICS DONE, TREATMENT AND THE OUTCOME. THERE IS INSUFFICIENT INFORMATION TO CONCLUDE WHETHER A PERMANENT INJURY OR IMPAIRMENT OCCURRED. THERE IS NO CONSUMER CONTACT INFORMATION AND NO ADDITIONAL INFORMATION CAN BE OBTAINED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE AND ASSESSMENT WILL BE REVIEWED AGAIN ACCORDINGLY. MOREOVER, THE RAW MATERIAL DOCUMENTATION FOR THE ADHESIVE AND BACKING OF BAND AID BRAND TRU STAY SHEER BANDAGES WERE REVIEWED AND STATE THAT NICKEL IS NOT PRESENT IN THE PRODUCT. D1, D2, D3, D4: THIS REPORT IS FOR ONE (BAND AID BRAND TRU STAY SHEER BANDAGES 80CT USA 381370046691 381370046691USA 381370046691 USA LOT/CTRL # NI. D4: UDI #: (B)(4). UPC #: 381370046691. LOT #: NI. EXPIRATION DATE: NA. D10: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. THE RAW MATERIAL DOCUMENTATION FOR THE ADHESIVE AND BACKING OF BAND AID BRAND TRU STAY SHEER BANDAGES WERE REVIEWED AND STATE THAT NICKEL IS NOT PRESENT IN THE PRODUCT. H6: HEALTH EFFECT CLINICAL CODE: E0402 ALSO REFERS TO CONSUMER ALLEGED ABOUT ¿ALLERGIC REACTION (HAD A SEVERE REACTION DESCRIBED AS ALMOST LOST FINGER.) 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

    FDA SHARED A CONSUMER REPORTED EVENT, VIA MW5144875, REGARDING AN UNKNOWN CONSUMER WHO STATED THE FOLLOWING: ¿I PURCHASED BAND-AID TRUE-STAY SHEER 80 ASSORTED SIZES BY JOHNSON+JOHNSON. THE PRODUCT DID NOT INCLUDE THE LIST OF HARMFUL CHEMICALS AND ALLERGENS AND WAS MARKETED AS SAFE FOR USE. PATENT #(B)(4). I HAD A SEVERE REACTION TO THE SECRET USE OF NICKEL. I AM DEATHLY ALLERGIC AND ALMOST LOST MY FINGER AFTER 10-MINS OF EXPOSURE. REQUIRE EVERY SINGLE PRODUCT ADVERTISED AS A HEALTH PRODUCT TO INCLUDE HAZARDOUS CHEMICALS, COMMON ALLERGENS, AND POISONOUS SUBSTANCES. I SHOULD NOT ALMOST LOOSE MY FINGER FROM "ALLERGY SAFE" BRANDED BAND-AIDS. SHAME ON YOU FOR ALLOWING THIS INTENTIONAL DISREGARD FOR THE SAFETY OF HUMANITY. OUTCOMES ATTRIBUTED TO ADVERSE EVENT: REQUIRED INTERVENTION, OTHER SERIOUS OR IMPORTANT MEDICAL EVENT, LIFE THREATENIN.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002915 BAND AID BRAND TRU STAY SHEER BANDAGES / SHEER TAPE AND BANDAGE KGX JOHNSON & JOHNSON CONSUMER INC 381370046691 381370046691

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other