BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALINE BREAST IMPLANT (L) 300CC

    MDR report key: 5986682 · Received September 21, 2016

    Report

    Report Number
    MW5065095
    Event Type
    Injury
    Date Received
    September 21, 2016
    Date of Event
    September 9, 2016
    Report Date
    September 15, 2016
    Manufacturer
    UNK
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD A PREVIOUS BREAST RECONSTRUCTION IN 1999 WITH A SALINE IMPLANT WHICH IS NOW LEAKING. THE BREAST IMPLANT HAS DEFLATED. PT HAS HISTORY OF BREAST CA (2011) AND HAD UNDERGONE A L LUMPECTOMY FOLLOWED BY RADIATION IN 2011. ALSO HAD R BREAST IMPLANT DEFLATED AND REPLACED IN (B)(6) 2015. PATIENT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2016 FOR THE FOLLOWING PROCEDURE: "L BREAST RECONSTRUCTION WITH SALINE IMPLANT; EXPLANTATION OF L IMPLANT, 1 BREAST CAPSULOTOMY L PARTIAL CAPSULECTOMY." FINDINGS: DEFLATED L BREAST SALINE IMPLANT, CALCIFIED CAPSULAR CONTRACTURE OF L BREAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620744 SALINE BREAST IMPLANT (L) 300CC SALINE BREAST IMPLANT (L) 300CC FWM UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention