BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST PROSTHESIS

    MDR report key: 103718 · Received June 30, 1997

    Report

    Report Number
    103718
    Event Type
    Injury
    Date Received
    June 30, 1997
    Date of Event
    May 2, 1997
    Report Date
    May 7, 1997
    Manufacturer
    MENTOR H/S, INC. ATTN: PRODUCT EVAL. DEPT.
    Product Code
    FWM
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD BILATERAL BREAST IMPLANTS IN 1991. BOTH HAVE RUPTURED AND PT ADMITTED TO HOSPITAL FOR BILATERAL AUGMENTATIONS, AND MASTOPEXY. BREASTS WERE REPLACED WITH SALINE-FILLED IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREAST PROSTHESIS Implant SALINE BREAST PROSTHESIS FWM MENTOR H/S, INC. ATTN: PRODUCT EVAL. DEPT. UNK R=59493 L=59999

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention