BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASOPORE STANDARD 8CM

    MDR report key: 5059585 · Received September 7, 2015

    Report

    Report Number
    0001811755-2015-03248
    Event Type
    Malfunction
    Date Received
    September 7, 2015
    Date of Event
    December 10, 2014
    Report Date
    August 13, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    LYA
    PMA / PMN Number
    K052099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE DISCARDED.

    Additional Manufacturer Narrative · 1

    THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POTENTIAL DAMAGE TO THE PACKAGING OF THE DEVICE, IT WAS NOTED THAT THE PACKAGING WAS WET WHEN STORED IN THE THEATRE FRIDGE. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POTENTIAL DAMAGE TO THE PACKAGING OF THE DEVICE, IT WAS NOTED THAT THE PACKAGING WAS WET WHEN STORED IN THE THEATRE FRIDGE. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590826 NASOPORE STANDARD 8CM SPLINT, INTRANASAL SEPTAL LYA STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1