BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENCORE SYSTEM

    MDR report key: 4072658 · Received August 29, 2014

    Report

    Report Number
    3008792120-2014-00002
    Event Type
    Injury
    Date Received
    August 29, 2014
    Date of Event
    July 3, 2012
    Report Date
    August 29, 2014
    Manufacturer
    SIESTA MEDICAL INC.
    Product Code
    ORY
    PMA / PMN Number
    K133680
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL, THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE EVENT. ALTHOUGH IT IS UNK IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT, THIS MDR IS BEING FILED FOR NOTIFICATION PURPOSE. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT A PT TREATED WITH TONGUE SUSPENSION HAD DEVELOPED A WOUND INFECTION. THE DEVICE WAS IMPLANTED APPROXIMATELY (B)(6) 2012. THE DR. PERFORMED A RE-INTERVENTION, TO TITRATE THE DEVICE, ON (B)(6) 2012 AND SHORTLY THEREAFTER THE PT DEVELOPED AN INFECTION WHICH WAS TREATED BY IRRIGATION, DRAINAGE AND ANTIBIOTICS. THE PERSISTENT INFECTION LED TO THE REMOVAL OF THE ENCORE SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527980 ENCORE SYSTEM TONGUE/HYOID SUSPENSION SYSEM ORY SIESTA MEDICAL INC. FG0002 513121A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention