BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1871788 · Received October 15, 2010

    Report

    Report Number
    1423500-2010-04466
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 21, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN.

    Description of Event or Problem · 1

    DURING FOLLOW-UP ON A RELATED COMPLAINT, IT WAS INDICATED THAT THIS PATIENT EXPERIENCED ANOTHER TWO PERITONITIS EVENTS. THE PATIENT'S PHYSICIAN BELIEVED THAT NONE OF THE EVENTS WERE RELATED TO DIANEAL OR EXTRANEAL, BECAUSE THE PHYSICIAN CONSIDERED THAT THE EVENT WAS CAUSED BY ASEPTIC TECHNIQUE. THE PHYSICIAN INDICATED THAT PERITONITIS WAS A POSSIBLE COMPLICATION OF PERITONEAL DIALYSIS (PD) THERAPY ITSELF, NOT OF PERITONEAL SOLUTIONS. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR THE FIRST OF THE TWO ADDITIONAL PERITONITIS EVENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DIANEAL-N PD-2 1.5% AND EXTRANEAL THERAPIES