BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1843042 · Received September 23, 2010

    Report

    Report Number
    1423500-2010-03668
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 1, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENT DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN.

    Description of Event or Problem · 1

    IN (B)(6) 2010, THE PATIENT STARTED PERITONEAL DIALYSIS (PD) TREATMENT. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON THE SAME DAY, A PERITONEAL EFFLUENT ANALYSIS AND CULTURE WERE PERFORMED. THE RESULTS OF THE CULTURE WERE UNKNOWN. ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH TOBRAMYCIN (40MG, DAILY, IP (INTRAPERITONEAL) AND REFLIN (1GM, DAILY, IP). PD THERAPY WAS ONGOING AS WELL AS REMEDIAL THERAPY WITH TOBRAMYCIN AND REFLIN. THE PERITONITIS WAS RESOLVING. NO CONCOMITANT MEDICATIONS WERE REPORTED. THE REPORTER BELIEVED THAT THE EVENT OF PERITONITIS WAS NOT RELATED TO PD THERAPY

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention DIANEAL PD2 ULTRABAG, EXTRANEAL VIAFLEX