BEUDAMED
    FDA Adverse Event Summary report: N

    ARISTA AH ABSORBABLE HEMOSTAT

    MDR report key: 2250804 · Received August 30, 2011

    Report

    Report Number
    2250804
    Date Received
    August 30, 2011
    Date of Event
    August 26, 2011
    Report Date
    August 30, 2011
    Manufacturer
    MEDAFOR, INC.
    Product Code
    LMG
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIANS HAVE REPORTED THAT THEIR PATIENTS DEVELOPED SMALL LYMPHOCYSTS AFTER ARISTA ABSORBABLE HEMOSTAT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARISTA AH ABSORBABLE HEMOSTAT ABSORBABLE HEMOSTAT LMG MEDAFOR, INC. * W1601418, W1579122,

    Patients

    Seq Age Sex Outcome Treatment
    1 *