BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRIER RECTANGLE - 50MM X 76M

    MDR report key: 6212310 · Received December 29, 2016

    Report

    Report Number
    0008010177-2016-00308
    Event Type
    Injury
    Date Received
    December 29, 2016
    Date of Event
    December 2, 2016
    Report Date
    December 29, 2016
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    FWP
    PMA / PMN Number
    K952677
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN STATED THE PATIENT CAME IN WITH INFLAMMATION AND IRRITATION AROUND THE EYE WHERE THE PRODUCT WAS IMPLANTED. NO REPLACEMENT WAS NEEDED AT THE TIME AND THE PRODUCT WILL NOT BE RETURNED. ALSO, IT IS UNKNOWN IF THE IMPLANT IS THE CAUSE OF THE INFLAMMATION. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT WAS DIAGNOSED WITH A HEMATOMA AND WAS TREATED WITH ANTIBIOTICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN STATED THE PATIENT CAME IN WITH INFLAMMATION AND IRRITATION AROUND THE EYE WHERE THE PRODUCT WAS IMPLANTED. NO REPLACEMENT WAS NEEDED AT THE TIME AND THE PRODUCT WILL NOT BE RETURNED. ALSO, IT IS UNKNOWN IF THE IMPLANT IS THE CAUSE OF THE INFLAMMATION. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862191 BARRIER RECTANGLE - 50MM X 76M IMPLANT FWP STRYKER LEIBINGER FREIBURG G003755

    Patients

    Seq Age Sex Outcome Treatment
    1