BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1790741 · Received August 10, 2010

    Report

    Report Number
    1423500-2010-02335
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 19, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) ON HOMECHOICE PERITONEAL DIALYSIS. ON AN UNREPORTED DATE IN 2010, A BREAK IN ASEPTIC TECHNIQUE OCCURRED. ON (B)(6) 2010, THE PATIENT EXPERIENCED ABDOMINAL PAIN AT HOME, AND WAS DIAGNOSED WITH PERITONITIS. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED FOR SERIOUS ABDOMINAL PAIN AND CLOUDY EFFLUENT. ON AN UNREPORTED DATE IN 2010, THE PATIENT BEGAN TREATMENT WITH CEFAZOLIN 1G X 2G/DAY AND GENTAMYCIN 40MG X 80MG/DAY. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PERITONITIS WAS IMPROVING AND THE PATIENT CONTINUED TO TAKE CEFAZOLIN AND GENTAMYCIN AT HOME WHILE REMAINING ON PERITONEAL DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ UNKNOWN MANUFACTURING FACILITY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 49 Hospitalization| R DIANEAL PD4 ULTRABAG