BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 337226 · Received June 11, 2001

    Report

    Report Number
    1423500-2001-00941
    Event Type
    Other
    Date Received
    June 11, 2001
    Date of Event
    May 12, 2001
    Report Date
    May 12, 2001
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    HOME PT (HP) REPORTS THEY WERE DIAGNOSED WITH PERITONITIS AFTER USING HOMECHOICE SETS DURING APD TREATMENT. HP REPORTS SETS ARE "DINGY LOOKING" AND IS UNCOMFORTABLE USING THE REMAINDER OF THEIR CURRENT BOX . UNIT RN REPORTS HP WAS HOSPITALIZED FOR PERITONITIS; HOWEVER, NOTES SHE DOES NOT HAVE ANY FURTHER DETAIL REGARDING THIS DIAGNOSIS AND TREATMENT. RN REPORTS HP HAS RESPONDED TO TREATMENT. RN DOES NOT REPORT ANY RELATION OF THE HOMECHOICE SETS TO THE DIAGNOSIS OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26794 HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORP. NA H01C24011

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| O