BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENCORE SYSTEM

    MDR report key: 4187711 · Received September 16, 2014

    Report

    Report Number
    3008792120-2014-00006
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    May 29, 2014
    Report Date
    September 15, 2014
    Manufacturer
    SIESTA MEDICAL INC.
    Product Code
    ORY
    PMA / PMN Number
    K133680
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE EVENT. ALTHOUGH IT IS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT, THIS MDR IS BEING FILED FOR NOTIFICATION PURPOSES. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT A PATIENT TREATED WITH TONGUE SUSPENSION HAD DEVELOPED A WOUND INFECTION. PHYSICIAN TREATED WITH ANTIBIOTICS HOWEVER IT DID NOT RESOLVE. THE PERSISTENT INFECTION LED TO THE REMOVAL OF THE ENCORE BONE ANCHORS AND SUTURE. PHYSICIAN REPORTS THAT THE WOUND HEALED FOLLOWING REMOVAL OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571912 ENCORE SYSTEM TONGUE/HYOID SUSPENSION SYSTEM ORY SIESTA MEDICAL INC. FG0002 504093A

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention UVULOPALATOPHARYNGOPLASTY (UPPP) AND TONSILLECTOMY