BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RTI SURGICAL INC CORTIVA 9.2X19.2CM DMM140

    MDR report key: 20255976 · Received September 19, 2024

    Report

    Report Number
    20255976
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    September 11, 2024
    Report Date
    September 12, 2024
    Manufacturer
    RTI SURGICAL, INC. (DBA RTI BIOLOGICS, INC.)
    Product Code
    FTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    RESIDENT WAS SOAKING MEDICAL DEVICE, THEY NOTICED IT DIDN'T LOOK HOW IT SHOULD AND ASKED NURSE TO HAVE NEW DEVICE ON STANDBY. SURGEON SCRUBBED IN AND CONFIRMED GETTING RID OF FAULTY DEVICE AND OPENING NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502864 RTI SURGICAL INC CORTIVA 9.2X19.2CM DMM140 MESH, SURGICAL FTM RTI SURGICAL, INC. (DBA RTI BIOLOGICS, INC.) 101137420

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown