BEUDAMED
    FDA Adverse Event Other Summary report: N

    DELFLEX 2.5% DEX. LM 5L, 2-PK

    MDR report key: 457458 · Received April 25, 2003

    Report

    Report Number
    1713747-2003-00041
    Event Type
    Other
    Date Received
    April 25, 2003
    Date of Event
    March 19, 2003
    Report Date
    April 25, 2003
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    KPO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT'S MOTHER REPORTS DURING PHONE CONVERSATION TODAY THAT SHE NOTICED POOLING OF SOLUTION ON THE TOP OF THE BAG AS IT SAT ON THE CYCLER TRAY. PT WAS TREATED WITH ANTIBIOTICS PROPHALACTICALLY. NO LOT NUMBER OR SAMPLE AVAILABLE. PT HAS BEEN ON PD FOR 3 YEARS. SOLUTION BAGS ARE STORED IN BASEMENT WHERE IT IS "COLD". PT STOCK IS ROTATED BY THE DELIVERY MAN AND PT USES THE ONES HE LEAVES IN FROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELFLEX 2.5% DEX. LM 5L, 2-PK SOLUTION BAG KPO OGDEN MANUFACTURING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other