BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1043534-2012-01156

    MDR report key: 2755939 · Received September 24, 2012

    Report

    Report Number
    1043534-2012-01156
    Event Type
    Injury
    Date Received
    September 24, 2012
    Date of Event
    July 13, 2010
    Report Date
    September 19, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LZO
    PMA / PMN Number
    K012091
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 4 OF 4 INVOLVED IN THIS PERITONITIS INCIDENT. THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT FROM A CONSUMER IN THE USA OF A FAILED KIDNEY FROM TRANSPLANT, SWELLED KIDNEY AND PERITONITIS IN MALE PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES FOR PERITONEAL DIALYSIS (PD). ACTION TAKEN WITH THE DIANEAL THERAPIES WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT HAD UNDERGONE KIDNEY TRANSPLANTATION WHICH FAILED. THE TRANSPLANTED KIDNEY WAS SUPPOSED TO SHRIVEL BUT INSTEAD THE KIDNEY GOT SWOLLEN AND HAD TO BE REMOVED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. TREATMENT WAS NOT REPORTED FOR THE EVENTS. THE OUTCOME OF THIS PERITONITIS EVENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LZO WRIGHT MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention DIANEAL PD4 AMBUFLEX| DIANEAL PD4 ULTRABAG| HOMECHOICE| DIANEAL PD4 AMBUFLEX| HOMECHOICE| DIANEAL PD4 ULTRABAG