BEUDAMED
    FDA Adverse Event Other Summary report: N

    MINI CAP DISCONNECT CAP WITH POVIDONE IODINE SOLUTION

    MDR report key: 3314155 · Received August 15, 2013

    Report

    Report Number
    MW5031626
    Event Type
    Other
    Date Received
    August 15, 2013
    Date of Event
    May 1, 2013
    Report Date
    August 15, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    KDJ
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS LETTER IS TO INFORM YOUR AGENCY THAT RECENTLY I CONTRACTED PERITONITIS, AS WELL AS A STAPH INFECTION. MY ILLNESS BEGAN ON (B)(6) WEEKEND AND LASTED THROUGHOUT THE MONTH OF (B)(6) 2013. I RECENTLY RECEIVED NOTICE OF A PRODUCT RECALL (PRODUCT CODE 5C4466P/LOT # GD893891) FROM BAXTER HEALTHCARE CORP, MAKERS OF THE MEDICAL DEVICE IN QUESTION - MINI CAP DISCONNECT CAP WITH POVIDONE IODINE SOLUTION. I HAVE SINCE COMPLIED WITH BAXTER'S "ACTIONS TO BE TAKEN" SUGGESTIONS AS EXPLAINED IN THE BAXTER URGENT RECALL NOTICE, AS WELL AS REQUESTED A COPY OF BAXTER'S HOME PT REPLY FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394557 MINI CAP DISCONNECT CAP WITH POVIDONE IODINE SOLUTION TRANSFER SET KDJ BAXTER HEALTHCARE CORP GD893891

    Patients

    Seq Age Sex Outcome Treatment
    1