BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-CAP WITH POVIDONE LODINE

    MDR report key: 1943101 · Received December 30, 2010

    Report

    Report Number
    1423500-2010-07445
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 6, 2010
    Manufacturer
    BAXTER HEALTHCARE - GUANGZHOU
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. THE SAMPLE WAS EVALUATED BY A CHEMIST IN THE CHEMICAL LAB. CHEMICAL TESTING RESULT WAS NORMAL.

    Description of Event or Problem · 1

    THIS REPORT ADDRESSES PRODUCT SAMPLE 2 OF 6. A CUSTOMER REPORTED TO BAXTER (B)(4) FIVE (5) MINICAPS WITH INADEQUATE IODINE. THERE WAS NO PATIENT INJURY AND MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP WITH POVIDONE LODINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - GUANGZHOU GM1005020

    Patients

    Seq Age Sex Outcome Treatment
    1