BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1951904 · Received January 7, 2011

    Report

    Report Number
    1423500-2011-00241
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 16, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    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 PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A PHYSICIAN AND A PHARMACIST FROM (B)(6) OF SEPTIC PERITONITIS WITH A CULTURE POSITIVE FOR (B)(6) IN A (B)(6) FEMALE PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY. AROUND (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX (DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON (B)(6) 2010, THE PATIENT EXPERIENCED SEPTIC PERITONITIS. THE PATIENT RECEIVED ROCEPHINE AND VANCOMYCIN (DOSE, FREQUENCY AND ROUTE NOT REPORTED) AS REMEDIAL TREATMENT. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. IT WAS NOT REPORTED IF EXTRANEAL HAD CONTINUED. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHYSICIAN BELIEVED THE PERITONITIS WAS NOT RELATED TO EXTRANEAL 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 77 YR Required Intervention EXTRANEAL VIAFLEX