BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR TISSUE EXPANDER

    MDR report key: 2950152 · Received January 17, 2013

    Report

    Report Number
    2950152
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    May 23, 2012
    Report Date
    January 17, 2013
    Manufacturer
    MENTOR CORPORATION
    Product Code
    LCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD RIGHT EXPANDER IMPLANT PLACED. A FEW DAYS POST-OP PATIENT DEVELOPED A SEROMA OF THE RIGHT SIDE. SITE WAS DRAINED, SWELLING, PAIN, AND ERYTHEMA CONTINUED AT THE SITE. PATIENT WAS ADMITTED AND SCHEDULED FOR THE IMPLANT TO BE REMOVED DUE TO SWELLING AND POSSIBLE INFECTION. CULTURES WERE DONE AND ALL WERE NEGATIVE BUT THE PATIENT DID HAVE SIGNIFICANT ERYTHEMA AND SWELLING CLINICALLY CONSISTENT WITH AN INFECTION. THERE WAS NO HARM TO THE PATIENT. A FEW MONTHS LATER, THE PATIENT HAD ANOTHER EXPANDER IMPLANTED WITH SUCCESSFUL OUTCOMES AND SWITCHED TO A SILICONE GEL IMPLANT A FEW MONTHS LATER ALSO WITH SUCCESSFUL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27100 MENTOR TISSUE EXPANDER EXPANDER, SKIN, INFLATABLE LCJ MENTOR CORPORATION 354-6214 6511908

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR