BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INAMED

    MDR report key: 1009143 · Received March 6, 2008

    Report

    Report Number
    MW5005817
    Event Type
    Injury
    Date Received
    March 6, 2008
    Date of Event
    May 30, 2007
    Report Date
    March 6, 2008
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PSEUDOMONAS INFECTION ACQUIRED DURING BREAST AUGMENTATION SURGERY. I SUFFERED WITH SEVERE PAIN ALMOST TO THE POINT OF SUICIDE. MY PLASTIC SURGEON REFUSED TO BELIEVE I HAD PAIN. I WENT TO MY PRIMARY CARE DR AS MY SURGEON IGNORED MY PLEAS FOR HELP. HE ADMITTED ME TO THE HOSP IN 2007 AND TEST REVEALED THERE WAS AN INFECTION AROUND THE IMPLANT. THE PS WAS NOTIFIED AND AGAIN IGNORED MY PLEA FOR HELP. THE NEXT MONTH, THE IMPLANT BROKE THROUGH THE INCISION SITE AND THE IMPLANTS WERE REMOVED. A CULTURE WAS SENT TO THE LAB AND THE RESULT WAS PSEUDOMONAS. I WAS GIVEN A 3 WEEK DOSE OF CIPRO. I MET WITH MY PS MONTHLY AND EXPRESSED MY CONCERNS THAT I STILL HAD PAIN AND BELIEVED I STILL HAD THE INFECTION. SHE CONTINUALLY DISMISSED MY COMPLAINTS. IN THE INTERIM I CONSULTED ANOTHER PLASTIC SURGEON AND BACK TO MY PRIMARY CARE DR AND EMERGENCY ROOMS WHERE EVERYONE FAILED TO BELIEVE OR HELP ME. IN 2008, AFTER I COULD NOT LONGER BREATHE, A LUNG DR ADMITTED ME TO THE HOSP. I HAD OSTEOMYELITIS AND THE CULTURE WAS PSEUDOMONAS. I HAD SURGERY FOR DEBRIDEMENT AND HAVE JUST FINISHED A 8 WEEKS COURSE OF IV ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INAMED SALINE FILLED BREAST IMPLANT FWM 468-680

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L