BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOW CORNING

    MDR report key: 357085 · Received October 10, 2001

    Report

    Report Number
    MW1023153
    Event Type
    Malfunction
    Date Received
    October 10, 2001
    Date of Event
    October 8, 2001
    Report Date
    October 10, 2001
    Manufacturer
    DOW CORNING
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SEEN IN CONSULTATION 10/2/01 WITH BILATERAL CAPSULAR CONTRACTURES WITH POSSIBLE RUPTURE OF GEL IMPLANTS. UNDERWENT TOTAL CAPSULECTOMIES WITH REPLACEMENT OF GEL IMPLANTS WITH GEL IMPLANTS. SURGERY REVEALED RIGHT GEL BLEED WITH CAPSULE SEVERE THICKENING WITH CALCIFICATIONS AND SILICONOMAS. LEFT GEL RUPTURE WITH SEVERE THICKENING AND CALCIFICATIONS AND SILICONOMAS CONTAINED IN POCKET. BOTH REPLACED WITH GEL IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45664 DOW CORNING LOW BLEED GEL 200CC FTR DOW CORNING UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR