BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMOOTH BECKER

    MDR report key: 65112 · Received January 24, 1997

    Report

    Report Number
    1645337-1996-00081
    Event Type
    Injury
    Date Received
    January 24, 1997
    Date of Event
    January 27, 1994
    Report Date
    January 23, 1997
    Manufacturer
    MENTOR H/S
    Product Code
    FTR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH DEVICE ON 5/25/90. SUBSEQUENTLY, ON 1/27/94 IT WAS NOTED THAT THE PROSTHESIS HAD RUPTURED AND THE PT DEVELOPED AUTOIMMUNE TYPE SYMPTOMS. NO ADD'L INFO REGARDING THIS OCCURRENCE IS AVAILABLE AT THIS TIME. THE MFR WILL REQUEST THE RETURN OF THE DEVICE FOR EVALUATION PURPOSES AND WILL CONTINUE ITS INVESTIGATION OF THIS OCCURRENCE. THIS REPORT WAS SUBMITTED TO THE FDA PURSUANT TO HEW "MDR REPORTING GUIDANCE FOR BREAST IMPLANTS" (MENTOR EFFECTIVE DATE, 2/10/92). ANY PERCEIVED INCREASE IN FREQUENCY OF EVENTS IS RELATED TO THE FILING OF REPORTS FOR EVENTS, WHICH WERE PREVIOUSLY NOT MDR REPORTABLE EVENTS PER 21 CFR 803.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMOOTH BECKER Implant EXPANDER/MAMARY PROSTH FTR MENTOR H/S NA 34179

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention