BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE

    MDR report key: 3241168 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19314
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A SERVICE HISTORY REVIEW AND DEVICE HISTORY RECORD REVIEW WERE PERFORMED WITH NO ISSUES FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED AN UMBILICAL HERNIA. THE PATIENT UNDERWENT ELECTIVE SURGICAL UMBILICAL HERNIA REPAIR IN AN OUTPATIENT SETTING. IT WAS UNKNOWN IF THE UMBILICAL HERNIA WAS PRE-EXISTING TO PERITONEAL DIALYSIS (PD) THERAPY OR IF THE HERNIA HAD BECOME AGGRAVATED OR WORSENED DUE TO PD THERAPY. FOLLOWING THE SURGERY, THE PATIENT WAS PLACED ON TEMPORARY HEMODIALYSIS FOR HEALING PURPOSES. AT THE TIME OF THIS REPORT, THE PATIENT HAD RECOVERED FROM THE HERNIA EVENT AND HAD RESTARTED PD THERAPY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340885 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL PD4 1.5% AND 2.5%