BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR ACCORDING TO LABELS AFFIXED TO RECORD

    MDR report key: 552843 · Received September 7, 2004

    Report

    Report Number
    MW1033482
    Event Type
    Injury
    Date Received
    September 7, 2004
    Manufacturer
    UNK
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM RPTR 9/28/04: THIS REPORT AMENDS ORIGINAL MEDWATCH REPORT. PT MEDICAL RECORDS CONFIRM THAT PT NEVER HAD REPLACEMENT IMPLANTS.

    Description of Event or Problem · 1

    PT MEDICAL RECORDS CONFIRM THAT PT NEVER HAD REPLACEMENT IMPLANTS. PT DEVELOPED CAPSULAR CONTRACTURES FROM THE 1986 MAMMARY PROSTHESES AND HAD TO UNDERGO A REVISION BY SAME PHYSICIAN IN 1997. IMPLANTS REMAIN IN SUBGLANDULAR POCKETS AND OVER SEVERAL YEARS BECAME ENCAPSULATED. PT DEVELOPED MEDICAL PROBLEMS AND SYMPTOMS ASSOCIATED WITH SILICONE GEL IMPLANTS. SIXTEEN YEARS LATER BILATERAL TOTAL ABLATIVE CAPSULECTOMIES WERE PERFORMED TO REMOVE IMPLANTS WHICH WERE GROSSLY RUPTURED. CAPSULES HAD HARDENED AND CALCIFIED RESULTING IN THINNING OF OVERLYING BREAST TISSUE. BREAST RECONSTRUCTION SECONDARY TO PROBLEMS WITH SILICONE IMPLANTS WAS DONE. THE REMOVED IMPLANTS WERE IDENTIFIED BY DIRECT INSPECTION BY THE PATHOLOGIST AS HAVING EMBOSSED CONCENTRIC RINGS. SUSPECT MEDICAL DEVICE INFO WAS INCORRECTLY STATED AS MENTOR. IMPLANTS HAVE ATTRIBUTES OF AMERICAN HEYER-SCHULTE IMPLANTS AND NOT MENTOR. THE ISSUE ARISES REGARDING THE AUTHENTICITY OF PRODUCT IDENTIFICATION LABELS PROVIDED AS PART OF PT'S RECORDS. IMPLANTS SHIPPED DIRECTLY FROM HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR ACCORDING TO LABELS AFFIXED TO RECORD BILATERAL SILICONE GEL BREAST IMPLANTS FTR UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R| S