BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCELL GEL-FILLED MAMMARY

    MDR report key: 205297 · Received December 30, 1998

    Report

    Report Number
    MW1015400
    Event Type
    Injury
    Date Received
    December 30, 1998
    Report Date
    December 21, 1998
    Manufacturer
    MCGHAN MEDICAL CORP.
    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

    A 42 YEAR OLD WHITE GRAVIDA 0 FEMALE, STATUS POST BILATERAL SUBMUSCULAR TRANSAXILLARY 200CC TEXTURED GEL SALINES (MCGHAN) PLACED FOR AUGMENTATION 03/20/1990. PT DENIES DECREASE IN SIZE OR HISTORY OF TRAUMA. PT REPORTS IMPLANTS ARE MIGRATING LATERALLY, AND HAVE ALWAYS BEEN TENDER. PT IS MOST CONCERNED WITH THE DEVELOPMENT OF INCREASED SYMPTOMS. PT COMPLAINS OF: ARTHRALGIAS (POSITIVE AM STIFFNESS)/MYALGIAS, PARESTHESIAS/DYSETHESIAS, SPASMS, SWELLING, FATIGUE, SLEEP DISTURBANCES, DIZZINESS, MEMORY LOSS, DRY EYES, HAIR LOSS, ORAL SORES, RASHES, SENSITIVITY TO SUN, SHORTNESS OF BREATH, COUGH, CHEST PAIN, COSTOCHRONDRITIS, CHOKING SENSATION, SKIN TIGHTENING, WEIGHT GAIN, GASTROINTESTINAL/GENITOURINARY DISTURBANCES, AND LOSS OF LIBIDO. PT OTHERWISE HEALTHY. DEVICES ARE NOT AVAILABLE, ARE BEING HELD FOR GRAMSTAIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOCELL GEL-FILLED MAMMARY Implant 200CC FTR MCGHAN MEDICAL CORP. STYLE: 100 LEFT DP7220
    2 BIOCELL GEL-FILLED MAMMARY Implant 80CC FTR MCGHAN MEDICAL CORP. STYLE: 100 RIGHT DR1707

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other| S