BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE GEL BREAST IMPLANTS

    MDR report key: 290139 · Received July 25, 2000

    Report

    Report Number
    MW1019592
    Event Type
    Injury
    Date Received
    July 25, 2000
    Report Date
    May 18, 1998
    Manufacturer
    DOW CORNING
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    "S/P B SUBGL INFRA DC GELS ( ? SIZE) FOR AUGMENTATION. C/O IMMEDIATE FIRMNESS WITH RECENT PAIN. DENIES H/O TRAUMA OR DECREASED SIZE. IF ANYTHING, BREASTS ARE LARGER. ARTHRALGIAS/MYALGIAS, NUMBNESS, CHRONIC FATIGUE, SLEEP DISTURB, REOCCURRING INFECTIONS INC URI'S, UTI'S, YEAST, SINUSITIS, COSTOCHONDRITIS, C/O HA'S, MEMORY LOSS, DRY MUCUS MEMBRANES, HAIR LOSS, RASHES, SOB, CHEST PAINS, CHOKING SENS, WGT GAIN, ELEVATED TRIGLYCERIDES, CONSTIPATION, BOWEL DISTURB, AND ABD PAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE GEL BREAST IMPLANTS UNK FTR DOW CORNING UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other| S