BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND HYDROSEAL BANDAGES ALL PURPOSE

    MDR report key: 21136382 · Received January 13, 2025

    Report

    Report Number
    2214133-2025-00001
    Event Type
    Injury
    Date Received
    January 13, 2025
    Report Date
    December 23, 2024
    Manufacturer
    KENVUE BRANDS, LLC
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    KENVUE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH KENVUE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, KENVUE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AND ADMISSION THAT THE DEVICE, KENVUE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IN AUGUST 2023 JOHNSON & JOHNSON¿S CONSUMER HEALTH BUSINESS SEPARATED FROM JOHNSON & JOHNSON, AND WE BECAME AN INDEPENDENT PUBLIC COMPANY, KENVUE. AS PART OF OUR ONGOING EVOLUTION, KENVUE UPDATED THE NAME OF ITS US OPERATING COMPANY, JOHNSON & JOHNSON CONSUMER INC. (¿JJCI¿) TO ¿KENVUE BRANDS LLC¿ ON OCTOBER 28, 2024. KENVUE RECENTLY MOVED TO ITS NEW CORPORATE HEADQUARTERS IN SUMMIT NJ. ITS PREVIOUS CORPORATE HEADQUARTERS WAS 199 GRANDVIEW ROAD, SKILLMAN, NJ 08558. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A5: ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D4: THIS REPORT IS FOR ONE (1) BAND AID BRAND HYDROSEAL BANDAGES ALL PURPOSE UNSPECIFIED USA NOT APPLICABLE BAHYBAUSUNSP, LOT NUMBER - NI. D4: 510(K) EXEMPT DEVICE I COMPLAINT. UDI, UPC, LOT NUMBER AND EXPIRATION DATE ARE NOT AVAILABLE FOR REPORTING. D9: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. H6: E2330 ¿ E172003 REFERS TO THE CONSUMER ALLEGED RED SQUARE ON THE SKIN (CONTACT DERMATITIS). THIS CASE IS BEING SUBMITTED AS AN OVERABUNDANCE OF CAUTION. CASE ASSESSED AS A NON-SERIOUS ADVERSE EVENT FOR BANDAGE RELATED EVENT. IT WAS REPORTED THAT THE PRODUCT ¿LEFT RED SQUARE ON THE PATIENT¿S SKIN (DERMATITIS CONTACT/ADHESIVE TAPE ALLERGY)¿, NO EXPLICIT REPORT OF ANY HCP DIAGNOSIS. AS PER OVERALL DETAILS IN REPORTED INFORMATION, EVENT INTERPRETED AS ALLERGIC CONTACT DERMATITIS (CODED TO HEALTH EFFECT CLINICAL CODE CONTACT DERMATITIS: APPLICATION SITE PHYSICAL SKIN REACTION AND DETERMINANT: DERMATITIS DUE TO CODING LIMITATION, SUBSUMED ¿RED¿). CONCURRENT CONDITION AND CONCOMITANT MEDICATIONS NOTED. CONSUMER CONSULTED HCP FOR EVENT ATTRIBUTED TO PRODUCT BUT NO DETAILS OF TREATMENT REPORTED. BASED ON AVAILABLE INFORMATION, NO HOSPITALIZATION, NO SIGNIFICANT INTERVENTION ATTRIBUTED TO PRODUCT USE AND NO OTHER SERIOUSNESS CRITERIA MET. B5 FULL NARRATIVE FROM MEDWATCH RECEIVED UNDER UNT-(B)(4): HYDROSEAL DRESSING LEAVES RED SQUARE ON SKIN [ADHESIVE TAPE ALLERGY] CASE DESCRIPTION: THIS UNITED STATES CASE IS A SOLICITED REPORT RECEIVED ON 10 DEC 2024, FROM A CONSUMER FROM A PATIENT SUPPORT PROGRAM VIA (B)(4) SPECIALTY PHARMACY. THIS 51-YEAR-OLD, 174 LBS, FEMALE PATIENT BEGAN THERAPY WITH REMODULIN (TREPROSTINIL SODIUM, CONCENTRATION 5.0 MG/ML), ON (B)(6)B2023 FOR PRIMARY PULMONARY ARTERIAL HYPERTENSION. THE CURRENT DOSE WAS REPORTED AS 0.08 G/KG, CONTINUOUS VIA INTRAVENOUS (IV) ROUTE. THE PATIENT REPORTED THAT THE HYDROSEAL DRESSING LEFT RED SQUARE ON THE PATIENT¿S SKIN (DERMATITIS CONTACT). CO-SUSPECT PRODUCT INCLUDED: HYDROSEAL DRESSING. CONCOMITANT MEDICATIONS INCLUDED: VITAMIN B-12, KLOR-CON (POTASSIUM CHLORIDE), ADEMPAS (RIOCIGUAT), MIRENA (LEVONORGESTREL), IPRATROPIUM/ALBUTEROL, MEGESTROL ACETATE, LASIX (FUROSEMIDE), LORAZEPAM, NAPROXEN, FLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE), DOXYCYCLINE HYCLATE, METHIMAZOLE, LEVOTHYROXINE SODIUM, IRON, VENTOLIN HFA (SALBUTAMOL SULFATE), ASPIRIN EC, FIBERCON (POLYCARBOPHIL CALCIUM), OXYGEN, MIDODRINE HCL, POLYETHYLENE GLYCOL, FUROSEMIDE, AZITHROMYCIN, DIPHENHYDRAMINE HCL, AMBRISENTAN, VITAMIN C AND POTASSIUM CHLORIDE. RELEVANT MEDICAL HISTORY INCLUDED: PRIMARY PULMONARY ARTERIAL HYPERTENSION. ACTION TAKEN WITH IV REMODULIN WAS NOT REPORTED FOR THE EVENT OF DERMATITIS CONTACT. AT THE TIME OF REPORTING, THE OUTCOME OF DERMATITIS CONTACT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE CAUSALITY FOR THE EVENT OF DERMATITIS CONTACT WITH IV REMODULIN. THE REPORTER¿S CAUSALITY FOR THE EVENT OF DERMATITIS CONTACT WITH HYDROSEAL DRESSING WAS CONSIDERED TO BE POSSIBLY RELATED. SUSPECT MEDICATION #1: TREPROSTINIL SODIUM (IV) (TREPROSTINIL SODIUM) INJECTION, 5.0 MG/ML DIAGNOSIS FOR USE #1: PRIMARY PULMONARY ARTERIAL HYPERTENSION (PULMONARY ARTERIAL HYPERTENSION) CONCOMITANT MEDICAL PRODUCTS: 1) VITAMIN B-12 (CYANOCOBALAMIN), 2) KLOR-CON (POTASSIUM CHLORIDE), 3) ADEMPAS (RIOCIGUAT), 4) MIRENA (LEVONORGESTREL), 5) IPRATROPIUM/ALBUTEROL (IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE), 6) MEGESTROL ACETATE (MEGESTROL ACETATE), 7) LASIX (FUROSEMIDE), 8) LORAZEPAM (LORAZEPAM), 9) NAPROXEN (NAPROXEN) TABLET, 10) FLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE), 11) DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE), 12) METHIMAZOLE (THIAMAZOLE), 13) LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM), 14) IRON (IRON), 15) VENTOLIN HFA (SALBUTAMOL SULFATE), 16) ASPIRIN EC (ACETYLSALICYLIC ACID), 17) FIBERCON (POLYCARBOPHIL CALCIUM), 18) OXYGEN (OXYGEN), 19) MIDODRINE HCL (MIDODRINE HYDROCHLORIDE), 20) POLYETHYLENE GLYCOL (MACROGOL), 21) FUROSEMIDE (FUROSEMIDE), 22) AZITHROMYCIN (AZITHROMYCIN), 23) DIPHENHYDRAMINE HCL (DIPHENHYDRAMINE HYDROCHLORIDE), 24) AMBRISENTAN (AMBRISENTAN), 25) VITAMIN C (ASCORBIC ACID, BETACAROTENE, ROSA CANINA), 26) POTASSIUM CHLORIDE (POTASSIUM CHLORIDE). 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

    EVENT WAS REPORTED VIA MEDWATCH/FDA UNT- (B)(4) ON 23-DEC-2024 THAT 51-YEAR-OLD, 174LBS, FEMALE PATIENT BEGAN THERAPY WITH REMODULIN, TREPROSTINIL SODIUM, CONCENTRATION 5.0 MG/ML, ON (B)(6) 2023 FOR PRIMARY PULMONARY ARTERIAL HYPERTENSION VIA INTRAVENOUS ROUTE AND THE HYDROSEAL DRESSING PRODUCT WAS USED. THE PATIENT REPORTED THAT THE HYDROSEAL DRESSING PRODUCT LEFT RED SQUARE ON THE PATIENT¿S SKIN, DERMATITIS CONTACT. THE PATIENT SOUGHT MEDICAL INTERVENTION, BUT NO DETAILS OF TREATMENT REPORTED. THERE IS NO ADDITIONAL INFORMATION WITH REGARDS TO OUTCOME FOR THIS PATIENT REGARDING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461002 BAND AID BRAND HYDROSEAL BANDAGES ALL PURPOSE DRESSING, WOUND, OCCLUSIVE NAD KENVUE BRANDS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention