BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 MF RE-STERILIZABLE SIZER

    MDR report key: 4121297 · Received September 22, 2014

    Report

    Report Number
    2024601-2014-00495
    Event Type
    Injury
    Date Received
    September 22, 2014
    Date of Event
    January 13, 2014
    Report Date
    February 6, 2014
    Manufacturer
    ALLERGAN
    Product Code
    MRD
    PMA / PMN Number
    K831566
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABILITY FOR RETURN IS UNKNOWN. THE EVENTS OF DRAINAGE, EDEMA, INFLAMMATION, AND ERYTHEMA ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. RE-STERILIZABLE SIZERS ARE TEMPORARY DEVICES, AND ARE NOT INTENDED TO BE USED AS A PERMANENT IMPLANT. THEY SHOULD ONLY BE USED FOR TEMPORARY INTRAOPERATIVE PLACEMENT, TO ASSIST THE SURGEON IN PERMANENT IMPLANT SIZE SELECTION. THESE EVENTS ARE BEING REPORTED BECAUSE MEDICAL INTERVENTION WAS REQUIRED, ALTHOUGH DEVICE-RELATEDNESS HAS NOT BEEN ESTABLISHED.

    Description of Event or Problem · 1

    REGULATORY AGENCY REPORTED PATIENT WAS IMPLANTED WITH A SILICONE GEL RESTERLIZABLE BREAST IMPLANT SIZER ON (B)(6) 2013. POST IMPLANT, PATIENT EXPERIENCED LEFT SIDE "DRAINAGE FROM THE INCISION SITE," WITH "PAIN, WARMTH, REDNESS AND SWELLING TO THE UPPER POLE." PATIENT WAS TREATED WITH ORAL ANTIBIOTICS, AND THE BREAST DEVICE WAS EXPLANTED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587528 STYLE 410 MF RE-STERILIZABLE SIZER MRD ALLERGAN NA 2514820

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention