BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTE EAR CLYLINDER

    MDR report key: 7782591 · Received August 14, 2018

    Report

    Report Number
    0001811755-2018-01580
    Event Type
    Malfunction
    Date Received
    August 14, 2018
    Date of Event
    July 17, 2018
    Report Date
    October 19, 2018
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    NHB
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED PRODUCT INVOLVED WITH THIS EVENT WAS RETURNED FOR EVALUATION. ON RECEIPT OF THE PRODUCT THE PRODUCT BLISTER PACK WAS OBSERVED TO BE OPEN. THE PACKAGING DEVELOPMENT ENGINEER CONCLUDED THAT THE ROOT CAUSE FOR THE OPEN PACK WAS UNDETERMINED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND ALL MANUFACTURING SPECIFICATIONS WERE MET DURING THE TIME OF MANUFACTURE OF THIS PRODUCT. IFU # 5400-030-701 REV. NONE WAS ALSO REVIEWED AND CONTAINS THE NOTE; "STERILE ONLY IF THE PACKAGE IS UNOPENED AND UNDAMAGED. DO NOT USE IF THE PACKAGE IS OPEN OR DAMAGED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A POTENTIAL STERILITY BREACH ON THE PACKAGING OF THE DEVICE. IT WAS ALSO REPORTED THAT IT WAS NOTICED PRIOR TO THE PROCEDURE. IT WAS FURTHER REPORTED THAT THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS 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 THERE WAS A POTENTIAL STERILITY BREACH ON THE PACKAGING OF THE DEVICE. IT WAS ALSO REPORTED THAT IT WAS NOTICED PRIOR TO THE PROCEDURE. IT WAS FURTHER REPORTED THAT THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621829 FORTE EAR CLYLINDER POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE NHB STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA