BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUTCHISON SALINE MAMMARY IMPLANT

    MDR report key: 276416 · Received May 4, 2000

    Report

    Report Number
    2320466-2000-00033
    Event Type
    Other
    Date Received
    May 4, 2000
    Date of Event
    February 17, 2000
    Report Date
    April 18, 2000
    Manufacturer
    BIOSIL, LTD
    Product Code
    FWN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEFLATION OF THE RIGHT BREAST IMPLANT, FOLLOW BY EXPLANTATION AND REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUTCHISON SALINE MAMMARY IMPLANT SALINE BREAST IMPLANT FWN BIOSIL, LTD SMOOTH ROUND S2590/1

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other