BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESTEEM

    MDR report key: 3022472 · Received March 12, 2013

    Report

    Report Number
    3004007782-2013-00016
    Event Type
    Other
    Date Received
    March 12, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ENVOY MEDICAL
    Product Code
    OAF
    PMA / PMN Number
    P090018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS TREATED WITH ANTIBIOTICS.

    Description of Event or Problem · 1

    EXPLANT OF DEVICE TO SUPPORT TREATMENT OF INFECTION INITIAL IMPLANT DATE (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104509 ESTEEM OAF ENVOY MEDICAL 2001 EMC0004926

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other