BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAPS

    MDR report key: 18385235 · Received December 22, 2023

    Report

    Report Number
    1416980-2023-06720
    Event Type
    Injury
    Date Received
    December 22, 2023
    Report Date
    December 22, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K152129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE ¿ THE PATIENT EXPERIENCED PERITONITIS TWICE LAST YEAR (2022). D4: LOT # - THE PATIENT USED RECALLED MINICAPS ASSOCIATED WITH FA-2023-003. E1: INITIAL REPORTER FIRST NAME - (B)(6). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED OR TREATED FOR THE PERITONITIS EVENTS. AT THE TIME OF THIS REPORT, THE PATIENT HAD RECOVERED FROM PERITONITIS. THE ACTION TAKEN WITH PD THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232537 MINICAPS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other NI.