BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAMMARY IMPLANT

    MDR report key: 38153 · Received September 13, 1996

    Report

    Report Number
    38153
    Event Type
    Injury
    Date Received
    September 13, 1996
    Date of Event
    July 25, 1996
    Report Date
    August 19, 1996
    Manufacturer
    MCGHAN MEDICAL CORPORATION
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ALLEGED EFFUSION AND ABSCESS. FOLLOW-UP FINDINGS: POSSIBLE INFECTION OF UNKNOWN ETIOLOGY. REMOVAL OF (L) BREAST IMPLANT SECONDARY TO PERI-PROSTHETIC EFFUSION ABSCESS (L) BREAST.

    Description of Event or Problem · 2

    REMOVAL OF (L) BREAST IMPLANT 20 TO PERI-PROSTHETIC EFFUSION ABSCESS (L) BREAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMARY IMPLANT Implant MAMMARY IMPLANT FWM MCGHAN MEDICAL CORPORATION NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention
    2 66 YR Hospitalization