BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9614385-2003-00187

    MDR report key: 502145 · Received December 12, 2003

    Report

    Report Number
    9614385-2003-00187
    Event Type
    Injury
    Date Received
    December 12, 2003
    Date of Event
    October 9, 2003
    Product Code
    FWM
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    DEFLATION OF RIGHT SALINE BREAST IMPLANT FOLLOWED BY REPLACEMENT WITH ANOTHER BRAND. UNKNOWN IF INITIAL USE. ORIGINAL SURGERY WAS PERFORMED IN 2000 USING HUTCHISON HSH 450 SALINE-FILL IMPLANTS, FILLED TO A VOLUME OF 550CC WHICH EXCEEDS THE RECOMMENDED FILL VOLUME LIMIT OF 450-480CC BY 70CC. PT UNDERWENT UNILATERAL REPLACEMENT SURGERY IN 2003, WITH RIGHT IMPLANT BEING REPLACED WITH MCGHAN STYLE 68 SMOOTH ROUND SALINE-FILL BREAST IMPLANT, 550CC, FILLED TO 550CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FWM

    Patients

    Seq Age Sex Outcome Treatment
    1