BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARSYS

    MDR report key: 4657055 · Received March 24, 2015

    Report

    Report Number
    0002083993-2015-00001
    Event Type
    Injury
    Date Received
    March 24, 2015
    Date of Event
    February 25, 2015
    Report Date
    March 23, 2015
    Manufacturer
    COOK BIOTECH
    Product Code
    NXM
    PMA / PMN Number
    K053622
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF INITIAL REPORT FROM THE HEALTH CARE PROFESSIONAL - THE MFR CONDUCTED A REVIEW OF DEVICE HISTORY RECORDS AND DEVICE STERILIZATION PROCESSING RECORDS FOR LOT LB 775721 WHICH REVEALED NO ANOMALIES. DEVICE IS SINGLED-USE AND WAS NOT RETURNED FOR EVAL. SHOULD THE DEVICE BE RETURNED AT A LATER DATE A FOLLOW-UP MED-WATCH REPORT WILL BE FILED WITH SUBSEQUENT EVAL RESULTS. A REVIEW OF THE MFG COMPLAINT HANDLING SYSTEM DATABASE CONFIRMS THIS TO BE THE ONLY REPORTED EVENT OF THIS NATURE FOR THIS DEVICE FAMILY SINCE THE DEVICE WAS FIRST PLACED INTO COMMERICAL DISTRIBUTION (B)(6) 2005.

    Description of Event or Problem · 1

    HEALTH CARE PROFESSIONAL REPORTED POST-OPERATIVE INFLAMMATION AND POSSIBLE ALLERGIC REACTION FROM SUSPECTED USE OF SUBJECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196460 TARSYS EYELID SPACER/GRAFT. BIOLOGIC NXM COOK BIOTECH TS-121040 LB775721

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other