BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN MEDICAL CORP

    MDR report key: 117447 · Received June 26, 1997

    Report

    Report Number
    117447
    Event Type
    Injury
    Date Received
    June 26, 1997
    Date of Event
    March 13, 1997
    Report Date
    March 21, 1997
    Manufacturer
    MCGHAN MED CORP.
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BREAST IMPLANT RUPTURED REQUIRING REPLACEMENT SURGERY. D6: HOSP STAFF CALLED WITH INFO TO MCGHAN ON 3/13/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN MEDICAL CORP Implant BREAST IMPLANT FWM MCGHAN MED CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention