BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR CORP BREAST IMPLANT

    MDR report key: 10369 · Received November 9, 1993

    Report

    Report Number
    10369
    Event Type
    Injury
    Date Received
    November 9, 1993
    Date of Event
    October 8, 1993
    Report Date
    November 5, 1993
    Manufacturer
    MENTOR CORP.
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD BILATERAL BREAST IMPLANTS REMOVED. RIGHT IMPLANT HAD RUPTURED. THE PT HAD BEEN UNDERGOING A BIOPSY BY HER GENERAL SURGEON, SHE DEVELOPED A RUPTURE OF HER IMPLANT AND WAS SCHEDULED FOR REMOVAL A FEW DAYS LATER. PT HAS POSSESSION OF HER IMPLANTS. IMPLANT INFO OBTAINED FROM PHYSICIAN'S OFFICE. IMPLANT WAS NOT DONE AT FACILITY. EXPLANT DR WAS DIFFERENT FROM IMPLANT DR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR CORP BREAST IMPLANT Implant SALINE BREAST IMPLANT FWM MENTOR CORP. UNKNOWN 64644

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention