BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR CORP

    MDR report key: 377490 · Received February 14, 2002

    Report

    Report Number
    MW1024100
    Event Type
    Injury
    Date Received
    February 14, 2002
    Date of Event
    May 5, 1998
    Report Date
    February 14, 2002
    Manufacturer
    MENTOR
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    P HAD MENTOR SALINE TEXTURED BREAST IMPLANTS FOR AUGMENTATION. THEY STARTED NOTICING DISCOMFORT ABOUT 8 MONTHS TO A YEAR AFTER AUGMENTATION. AT TIMES THERE WAS SEVERE FATIGUE THAT LASTED WEEKS ON END. NO MEDICAL DR COULD DIAGNOSE AN EXACT ILLNESS. PT EXPERIENCED VISUAL DISTURBANCES THAT THEY WENT TO OPHTHOMOLOGIST FOR, AND THEY COULD NOT FIND THE CAUSE. PT'S MEMORY HAS SEEMED TO BECOME AFFECTED SLIGHTLY, BECOMING LESS SHARP. PT ALWAYS HAS HAD A SUPERIOR MEMORY PRIOR TO THE SALINE IMPLANTS. SLEEP PROBLEMS IE: INSOMNIA, DISTURBED SLEEP LASTING OVER 3 YEARS. IT'S BECOME NATURAL TO THE PT TO NOT EVER GET A "GOOD NIGHTS SLEEP". AGAIN, NO PHYSICIAN HAS DIAGNOSED WHY PT HAS THESE SYMPTOMS. ALL BLOOD TESTS EVER TAKEN HAVE ALWAYS BEEN WITHIN NORMAL RANGE. THE WORST OF THE ILLNESSES HAS BEEN DIARRHEA LASTING MONTHS ON END, WITH NO DIAGNOSABLE DISEASE. PT HAD COLONOSCOPY, SIGMOIDOSCOPY AND ANYTHING ELSE THEY COULD TEST, ALL COMING BACK WITH NORMAL RESULTS. PT HAS ENDED UP HAVING A FISSURECTOMY AND LATERAL SPHINCTERECTOMY BECAUSE OF THE DAMAGE TO BOWELS. PT'S TAKE ON THIS IS THEIR BODY WAS WORKING OVERTIME TO PURGE WHATEVER IT IS INSIDE OF THEM CAUSING AN ALLERGIC REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR CORP SALINE IMPLANT - TEXTURED, ROUND 300CC O/F TO 325CC FWM MENTOR * *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR