BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASOPORE DRESS 8CM FIRM 8/PK

    MDR report key: 4345501 · Received December 19, 2014

    Report

    Report Number
    0001811755-2014-04604
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    November 21, 2014
    Report Date
    November 21, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    LYA
    PMA / PMN Number
    K052009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR RETURN. A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NASOPORE PACKING HAD NOT DISSOLVED A WEEK AFTER INSERTION. IT WAS ALSO REPORTED THAT THE PATIENT SUFFERED SEVERE HEADACHES. THE PRODUCT WAS SUCTIONED OUT BY THE SURGEON. THERE WAS NO MEDICAL INTERVENTION OR SURGICAL DELAY REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NASOPORE PACKING HAD NOT DISSOLVED A WEEK AFTER INSERTION. IT WAS ALSO REPORTED THAT THE PATIENT SUFFERED SEVERE HEADACHES. THE PRODUCT WAS SUCTIONED OUT BY THE SURGEON. THERE WAS NO MEDICAL INTERVENTION OR SURGICAL DELAY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839051 NASOPORE DRESS 8CM FIRM 8/PK SPLINT, INTRANASAL SEPTAL LYA STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1