BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 83680 · Received April 9, 1997

    Report

    Report Number
    83680
    Event Type
    Other
    Date Received
    April 9, 1997
    Date of Event
    February 24, 1997
    Report Date
    March 7, 1997
    Manufacturer
    DOW CORNING CORP. MDR REPORTING & COMPLAINT INVESTIGATION
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    S/P R BREAST RECONSTRUCTION W/SILICONE IMPLANT. DEVELOPED CAPSULAR CONTRACTURE, QUESTION LOSS OF IMPLANT INTEGRITY WITH INCREASING LOSS OF PROJECTION AND POOR RECONSTRUCTIVE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant SILICONE BREAST IMPLANT FTR DOW CORNING CORP. MDR REPORTING & COMPLAINT INVESTIGATION * HH058150

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other