BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIPOSORBER LA-15

    MDR report key: 140028 · Received December 23, 1997

    Report

    Report Number
    2435151-1997-00001
    Event Type
    Other
    Date Received
    December 23, 1997
    Date of Event
    November 21, 1995
    Report Date
    December 23, 1997
    Manufacturer
    KANEKA CORP.
    Product Code
    MMY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT STARTED HIS FIRST LDL APHERESIS TREATMENT USING LIPOSORBER LA-15 SYS ON NOVEMBER 11, 1992. THE PT EXPERIENCED AN ADVERSE EVENT OF SUDDEN LOSS OF HEARING (RIGHT > LEFT) WITH VERTIGO IN ANOTHER COUNTRY ON NOVEMBER 21, 1995, AFTER 3500 ML OF PLASMA WAS TREATED. THE SYMPTOMS APPEARED TO HAVE ONLY BEEN PARTIALLY RESOLVED WITH CONTINUED POSSIBLE HEARING IMPAIRMENT IN THE PT'S RIGHT EAR. HOWEVER, THE TREATING PHYSICIAN HAS NOT SUPPLIED UPDATED INFO. THE PT HAS CONTINUED HIS LDL APHERESIS PROCEDURES AND HAS NOT HAD ANY FURTHER NEUROLOGICAL OR NEW HEARING PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIPOSORBER LA-15 LDL ADSORPTION COLUMN MMY KANEKA CORP. LIPOSORBER LA-15 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other