BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE PRO

    MDR report key: 3802557 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-14929
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THE PATIENT HAD A PRE-EXISTING HERNIA PRIOR TO HER STARTING PERITONEAL DIALYSIS THERAPY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT RETURNED, AN EVALUATION COULD NOT BE CONDUCTED. A REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO PREVIOUS SERVICE EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. THE CAUSE OF THE REPORTED HERNIA COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A HERNIA COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. IT WAS UNKNOWN IF THE PATIENT WAS DIAGNOSED WITH A HERNIA BEFORE OR AFTER STARTING PD THERAPY. THE PATIENT DID NOT RECEIVE ANY INTERVENTION FOR THE HERNIA AND THE HERNIA DID NOT WORSEN SINCE THE START OF PD THERAPY. THE PATIENT WAS NOT A CANDIDATE FOR SURGICAL REPAIR AT THE TIME OF THIS REPORT. THE PATIENT HAS NOT EXPERIENCED ANY OVERFILLS, INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENTS, OR HIGH DRAIN ALARMS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281857 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1