BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1691497 · Received May 17, 2010

    Report

    Report Number
    1423500-2010-00828
    Event Type
    Injury
    Date Received
    May 17, 2010
    Date of Event
    April 19, 2010
    Report Date
    April 28, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED THEREFORE NO EVALUATION WAS PERFORMED. THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT BY A PATIENT AND A PHYSICIAN FROM (B)(6) OF PERITONITIS IN A MALE PATIENT (B)(6) COINCIDENT WITH DIANEAL PD THERAPY. IN (B)(6) 2010, THE PATIENT BEGAN DIANEAL N PD-4 1.5, DIANEAL N PD-4 2.5 AND EXTRANEAL THERAPY. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS AND WAS ADMITTED TO THE HOSPITAL. HE WAS TREATED WITH UNSPECIFIED ANTIBIOTICS. ON (B)(6) 2010, HE RECOVERED FROM THE EVENT. IT IS UNKNOWN IF THE PATIENT EXPERIENCED AN EXIT SITE/CATHETER SITE INFECTION (TUNNEL INFECTION). IT WAS UNKNOWN IF ANY BACTERIOLOGICAL EXAMINATION WAS PERFORMED. THE PATIENT WAS RETRAINED OF ASEPTIC TECHNIQUE. THE PATIENT HAD NOT HAD PERITONITIS EPISODES WITHIN 4 WEEKS PRIOR TO CURRENT EPISODE. THE PHYSICIAN CONSIDERED THAT THE EVENT WAS NOT RELATED TO DIANEAL N AND EXTRANEAL THERAPY SINCE THE EVENT WAS CAUSED BY PATIENT TECHNIQUE, WHICH WAS DUE THE PATIENT BEING HEMIPLEGIC. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX UNKNOWN MANUFACTURING FACILITY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R DIANEAL N PD-4 1.5, DIANEAL N PD-4 2.5 AND EXTRANE