BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE BREAST IMPLANT RIGHT

    MDR report key: 3982805 · Received July 23, 2014

    Report

    Report Number
    3982805
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 21, 2014
    Manufacturer
    UNK
    Product Code
    FWM
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FEMALE PT HAS HISTORY OF MALIGNANT NEOPLASM AND UNDERWENT BILATERAL MASTECTOMIES IN 1994 AT ANOTHER FACILITY. THE PT PRESENTED TO THE OPERATING ROOM ON (B)(6) 2014 FOR REMOVAL OF RUPTURED BILATERAL SILICONE BREAST IMPLANTS. PROCEDURE: EXPLANTATION OF L SILICONE IMPLANT, RECONSTRUCTION LEFT BREAST WITH SALINE IMPLANT, LEFT SUPERIOR CAPSULOTOMY, LEFT. LEFT STRATTICE SLING SUSPENSION; REPOSITION LEFT BREAST. RIGHT PARTIAL CAPSULECTOMY; RIGHT CAPSULORRHAPHY; EXPLANTATION RIGHT RUPTURED SILICONE IMPLANT; RIGHT BREAST RECONSTRUCTION WITH SALINE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432085 SILICONE BREAST IMPLANT RIGHT SILICONE BREAST IMPLANT RIGHT FWM UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention