BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPATCH, UNKNOWN SIZE/PRODUCT ID

    MDR report key: 17692855 · Received September 6, 2023

    Report

    Report Number
    2648988-2023-00027
    Event Type
    Injury
    Date Received
    September 6, 2023
    Report Date
    September 29, 2023
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    FRO
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D9, G3, G6, H2, H3, H6, H10. THE BIOPATCH (ID UNKNOWN) 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.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    MEDWATCH: 2023-021170. "A 37 YEAR OLD, 174 LBS, FEMALE PATIENT BEGAN THERAPY WITH REMODULIN (TREPROSTINIL SODIUM, CONCENTRATION 5 MG/ML), ON (B)(6) 2017 FOR PRIMARY PULMONARY ARTERIAL HYPERTENSION. THE CURRENT DOSE WAS REPORTED AS 0.068 G/KG, CONTINUOUS VIA INTRAVENOUS (IV) ROUTE. ON AN UNREPORTED DATE, THE PATIENT WAS NOT FEELING WELL (MALAISE) AND WAS ALLERGIC TO BIOPATCH DRESSING (DERMATITIS CONTACT)." "CO-SUSPECT MEDICATION INCLUDED BIOPATCH (CHLORHEXIDINE GLUCONATE). CONCOMITANT MEDICATIONS INCLUDED OPSUMIT (MACITENTAN) AND ADEMPAS (RIOCIGUAT). RELEVANT MEDICAL HISTORY INCLUDED PRIMARY PULMONARY ARTERIAL HYPERTENSION." "ACTION TAKEN WITH IV REMODULIN WAS NOT REPORTED FOR THE EVENTS OF MALAISE AND DERMATITIS CONTACT. AT THE TIME OF REPORTING, THE OUTCOME OF MALAISE AND DERMATITIS CONTACT WAS UNKNOWN." "THE REPORTER DID NOT PROVIDE CAUSALITY FOR THE EVENTS OF MALAISE AND DERMATITIS CONTACT WITH IV REMODULIN. THE REPORTER'S CAUSALITY FOR THE EVENT OF DERMATITIS CONTACT WITH BIOPATCH WAS CONSIDERED TO BE POSSIBLY RELATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987412 BIOPATCH, UNKNOWN SIZE/PRODUCT ID ANTIMICROBIAL PRODUCTS FRO INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female ADEMPAS (RIOCIGUAT)| OPSUMIT (MACITENTAN)| REMODULIN (TREPROSTINIL NA, CONCENTRATION 5 MG/ML)