BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_INSTRUMENTSTIRE_PRODUCT

    MDR report key: 6976438 · Received October 25, 2017

    Report

    Report Number
    0001811755-2017-01975
    Event Type
    Injury
    Date Received
    October 25, 2017
    Date of Event
    September 27, 2017
    Report Date
    December 13, 2017
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    LYA
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT REPORTED IN THIS CASE DID NOT REPORT WHAT NASOPORE PRODUCT WAS USED. THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. A PRODUCT MALFUNCTION/DEFICIENCY WAS UNDETERMINED DUE TO THE LIMITED INFORMATION AVAILABLE. ATTEMPTS TO GET ADDITIONAL INFORMATION ON THIS EVENT WERE UNSUCCESSFUL. DUE TO THE LIMITED INFORMATION IT IS NOT POSSIBLE TO DETERMINE IF THE STRYKER PRODUCT CONTRIBUTED TO THE REPORTED EVENT. THE EVENT DID NOT INVOLVE A PRODUCT PROBLEM INDICATING A NON CONFORMITY OR UNANTICIPATED HAZARD. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. PRODUCT WAS USED IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PATIENT POST SURGERY THAT THE PATIENT REPORTED DIFFICULTIES. IT WAS FURTHER REPORTED THAT THE ALLEGED DIFFICULTIES INCLUDE AESTHETIC CHANGES DUE TO THREADS BEING TIED TOO TIGHTLY AND VISION ISSUES. NO FURTHER INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PATIENT POST SURGERY THAT THE PATIENT REPORTED DIFFICULTIES. IT WAS FURTHER REPORTED DIFFICULTIES INCLUDE AESTHETIC CHANGES DUE TO THREADS BEING TIED TOO TIGHTLY AND VISION ISSUES. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757701 UNKNOWN_INSTRUMENTSTIRE_PRODUCT SPLINT, INTRANASAL SEPTAL LYA STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other