BEUDAMED
    FDA Adverse Event Summary report: N

    SYNCHRON LX NO FOAM

    MDR report key: 2120808 · Received June 10, 2011

    Report

    Report Number
    2050012-2011-02257
    Date Received
    June 10, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LDT
    PMA / PMN Number
    K965240
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM: BECKMAN COULTER (B)(4), TO: BECKMAN COULTER (B)(4).

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    BECKMAN COULTER INC. (BCI) (B)(4) REPORTED THE NO FOAM BOTTLE LEAKED AROUND THE CAP. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX NO FOAM LX NO FOAM KIT 1X1L LDT BECKMAN COULTER INC. LX NO FOAM M102118

    Patients

    Seq Age Sex Outcome Treatment
    1