BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DWO CORNING BREAST IMPLANT

    MDR report key: 359955 · Received November 14, 2001

    Report

    Report Number
    MW1023338
    Event Type
    Injury
    Date Received
    November 14, 2001
    Date of Event
    December 1, 1979
    Report Date
    November 14, 2001
    Manufacturer
    DOW CORNING
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT STATED THEY HAD BILATERAL BREAST IMPLANT SURGERY. PT FELL IN 2000 AND HURT SHOULDER AND THE LEFT BREAST IMPLANT BURST. RPTR SAW LAWYER WHO GOT PT TO THE HOSP. THE RPTR COMPLAINED THAT THE HOSP FAILED TO MONITOR AND TREAT THEM PROPERLY. PT HAD TO SEE A PRIVATE PHYSICIAN TO GET FURTHER TREATMENT AND STILL ENDED UP GOING TO OTHER HOSPS. RPTR SAID THEY ARE STILL HAVING NAUSEA, PAIN AND THE IMPLANT MATERIAL HAS LEAKED INTO BODY AND THE RUPTURE HAS LEFT PT WITH DEFORMITY ANXIETY AND DEPRESSION. PT ALSO HAS OT TAKE MEDICATION ON A LONG TERM BASIS FOR THESE SYMPTOMS. RPTR ALSO STATED THEY MAY HAVE TO SEE A PSYCHIATRIST DUE TO PRESENT PROBLEMS WITH DEPRESSION. THE DEVICE STILL REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51461 DWO CORNING BREAST IMPLANT BREAST IMPLANT FTR DOW CORNING NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization