BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE

    MDR report key: 4792186 · Received May 22, 2015

    Report

    Report Number
    1416980-2015-22561
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    March 28, 2015
    Report Date
    May 1, 2015
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A RIGHT INCARCERATED HERNIA COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. ONE DAY AFTER ONSET, THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND A SURGICAL REPAIR OF THE HERNIA WAS PERFORMED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. PERITONEAL DIALYSIS THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336751 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R DIANEAL 2.5% PD4 AMBUFLEX