BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPATCH, UNKNOWN SIZE/PRODUCT ID

    MDR report key: 19539022 · Received June 14, 2024

    Report

    Report Number
    2648988-2024-00025
    Event Type
    Injury
    Date Received
    June 14, 2024
    Report Date
    June 14, 2024
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    FRO
    PMA / PMN Number
    K003229
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BIOPATCH WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    MEDWATCH 2024-012769. STUDY: 58-YEARS-OLD, 177 POUNDS, MALE PATIENT. "THE THERAPY BEGAN WITH REMODULIN (TREPROSTINIL SODIUM, CONCENTRATION 1.0 MG/ML) ON (B)(6) 2023 FOR SECONDARY PULMONARY ARTERIAL HYPERTENSION. THE CURRENT DOSE WAS REPORTED AS 0.0206 MICROGRAM/KG, CONTINUOUS VIA INTRAVENOUS (IV) ROUTE. SINCE AN UNREPORTED DATE IN (B)(6) 2024, THE PATIENT HAD SITE REDNESS AND SITE ITCHING AROUND CENTRAL LINE SITE (INJECTION SITE ERYTHEMA AND INJECTION SITE PRURITUS) FOR ABOUT 2WEEKS. THE OPSITE DRESSING HAD HELPED A BIT, BUT THE ITCHING AND REDNESS AT THE SITE CONTINUED." "CONCOMITANT MEDICATION INCLUDED: ADEMPAS (RIOCIGUAT), CLINDAMYCIN HCL, OMEPRAZOLE, WEGOVY (SEMAGLUTIDE), TYLENOL (PARACETAMOL), AMOXICILLIN, SODIUM CHLORIDE, PFIZER COVID-19 VACCINE (TOZINAMERAN), ALBUTEROL SULFATE HFA, BIKTARVY (BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE), OPSUMIT (MACITENTAN), PROBIOTIC & ACIDOPHILUS, SPIRONOLACTONE AND FUROSEMIDE. RELEVANT MEDICAL HISTORY INCLUDED: SECONDARY PULMONARY ARTERIAL HYPERTENSION." "ACTION TAKEN WITH IV REMODULIN WAS NOT REPORTED FOR THE EVENTS OF INJECTION SITE ERYTHEMA AND INJECTION SITE PRURITUS. AT THE TIME OF REPORTING, THE OUTCOME OF INJECTION SITE ERYTHEMA AND INJECTION SITE PRURITUS WAS NOT RESOLVED." "THE REPORTER DID NOT PROVIDE CAUSALITY FOR THE EVENTS OF INJECTION SITE ERYTHEMA AND INJECTION SITE PRURITUS." FOLLOW-UP INFORMATION: "CO-SUSPECT MEDICINAL PRODUCT INCLUDED BIOPATCH (CHLORHEXIDINE GLUCONATE). IT WAS REPORTED THAT THE PATIENT HAD ITCHING UNDER THE CENTRAL LINE DRESSING (DERMATITIS CONTACT) ESPECIALLY WHEN OUT IN THE HEAT AND WHEN CHLORHEXIDINE BIOPATCH WAS USED. 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 BIOPATCH WAS CONSIDERED TO BE POSSIBLY RELATED." FOLLOW-UP INFORMATION: "CO-SUSPECT MEDICATION INCLUDED: CHLORAPREP (CHLORHEXIDINE GLUCONATE, ISOPROPANOL). IT WAS REPORTED THAT PATIENT HAD SITE ITCHINESS (PREVIOUSLY REPORTED, INJECTION SITE PRURITUS) AND THE BANDAGE WAS IRRITATING HIS SITE (PREVIOUSLY REPORTED, DERMATITIS CONTACT). HE WAS ALLERGIC TO THE CHLORAPREP." "THE REPORTER¿S CAUSALITY FOR THE EVENT OF DERMATITIS CONTACT WITH CHLORAPREP WAS CONSIDERED TO BE POSSIBLY RELATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373789 BIOPATCH, UNKNOWN SIZE/PRODUCT ID ANTIMICROBIAL PRODUCTS FRO INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other ADEMPAS (RIOCIGUAT)| ALBUTEROL SULFATE HFA (SALBUTAMOL SULFATE)| AMOXICILLIN (AMOXICILLIN TRIHYDRATE)| BIKTARVY| CLINDAMYCIN HCL (CLINDAMYCIN HYDROCHLORIDE)| FUROSEMIDE (FUROSEMIDE)| OMEPRAZOLE (OMEPRAZOLE)| OPSUMIT (MACITENTAN)| PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN)| PROBIOTIC ACIDOPHILUS (LACTOBACILLUS ACIDOPHILUS)| SODIUM CHLORIDE (SODIUM CHLORIDE)| SPIRONOLACTONE (SPIRONOLACTONE)| TYLENOL (PARACETAMOL)| WEGOVY (SEMAGLUTIDE)