BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOW CORNING LOW PROFILE IMPLANTS

    MDR report key: 2143034 · Received April 15, 2011

    Report

    Report Number
    2143034
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    January 26, 2011
    Report Date
    April 14, 2011
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE STATUS POST SUBGLANDULAR SILICONE BREAST AUGMENTATION IN 1977. DEVELOPED CAPSULAR CONTRACTURE AND SUSPECTED RUPTURE OR LEAK BILATERAL BREAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOW CORNING LOW PROFILE IMPLANTS BREAST IMPLANT FTR 165 ML LOW PROFILE 1977

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other