BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NITINOL STAPLE

    MDR report key: 7982432 · Received October 18, 2018

    Report

    Report Number
    2031009-2018-00027
    Event Type
    Injury
    Date Received
    October 18, 2018
    Date of Event
    April 24, 2018
    Report Date
    May 14, 2018
    Manufacturer
    TRIMED INC
    Product Code
    JDR
    UDI-DI
    00842188108952
    PMA / PMN Number
    K112794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY PER FDA REQUEST.

    Description of Event or Problem · 0

    ON MAY 8TH, 2018 IT WAS REPORTED TO TRIMED THAT THERE WAS A INCIDENT OF INFECTION RELATED TO A SURGERY THAT INVOLVED THE TRIMED NITINOL STAPLE. ON MAY 13TH, TRIMED WAS GIVEN MORE INFORMATION ON THE INCIDENT, AND THAT THERE WERE SEVEN STAPLES INVOLVED IN THE ONE INCIDENT OF INFECTION. THERE WERE A TOTAL OF SEVEN STAPLES INVOLVED FROM LOTS 317003 (QUANTITY 3) AND LOT 317004 (QUANTITY 4). THIS INCIDENT WAS DISCOVERED AT (B)(6) HOSPITAL IN AUSTRALIA. AN ACTIVE INFECTION WAS DISCOVERED NEAR THE SURGICAL SITE WITHIN THE FIRST POST-OPERATIVE WEEK. THIS IS THE FIRST TIME THIS TYPE OF INCIDENT HAS BEEN REPORTED TO TRIMED WITH THE CONCOMITANT USE OF THE NITINOL STAPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823267 NITINOL STAPLE NITINOL STAPLE JDR TRIMED INC ES-10X10 317003 00842188108952

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Other| H