BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA JARIT

    MDR report key: 11693401 · Received April 20, 2021

    Report

    Report Number
    11693401
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    February 11, 2021
    Report Date
    March 18, 2021
    Manufacturer
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION
    Product Code
    HRQ
    UDI-DI
    10381780432876
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A KOCKER BROKE ON THE FIELD WHILE SURGEON WAS USING. BROKEN PIECES WERE RETRIEVED AND TAKEN OFF OF FIELD AND BAGGED. A FLAT PLATE IMAGE WAS TAKEN AND A RADIOLOGIST READ TO RULE OUT ANY RETAINED FRAGMENTS FROM BROKEN INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591952 INTEGRA JARIT HEMOSTAT HRQ INTEGRA LIFESCIENCES PRODUCTION CORPORATION 106-210 10381780432876

    Patients

    Seq Age Sex Outcome Treatment
    1