BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XEN 45 GTS

    MDR report key: 6211675 · Received December 28, 2016

    Report

    Report Number
    3007851988-2016-00004
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Date of Event
    September 1, 2016
    Report Date
    March 3, 2017
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING TIME OF THE EVENT AND WHETHER OR NOT A BACKUP DEVICE WAS USED WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. CLARIFICATION TO SERIAL NUMBER: (B)(4). DEVICE LABELING: PRECAUTIONS THE XEN GEL IMPLANT AND INJECTOR SHOULD BE CAREFULLY EXAMINED IN THE OPERATING ROOM PRIOR TO USE.

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE INJECTOR COMPONENTS WERE LOOSE IN THE BOX WITH NO OTHER PACKAGING COMPONENTS THE SYRINGE CASE HALVES AND CAM ASSEMBLY HALVES WERE SEPARATED IN THE BOX. THERE WAS NO IMPLANT IN THE UNIT NEEDLE OR THE PACKAGING. DEVICE HISTORY RECORDS POST LOT RELEASE FOR A MISSING GEL STENT ARE NOT REQUIRED FOR THE COMPLAINT BECAUSE THE ROOT CAUSE IS VERY UNLIKELY DUE TO A MANUFACTURING ISSUE. THE MOST LIKELY ROOT CAUSE IS EITHER THE DOCTOR OR SURGICAL STAFF TILTS THE INJECTOR AND THE GEL STENT FALLS OUT, OR WHEN THE RETENTION PLUG IS REMOVED FROM THE NEEDLE STATIC FORCE COULD POTENTIALLY CAUSE THE GEL STENT TO COME OUT OF THE NEEDLE.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED "NO XEN IMPLANT INSIDE THE INJECTOR."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED "NO XEN IMPLANT INSIDE THE INJECTOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858177 XEN 45 GTS - KYF ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R