BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITEK DOUBLE LUMNE BREAST IMPLANT

    MDR report key: 37252 · Received September 11, 1996

    Report

    Report Number
    MW1009905
    Event Type
    Injury
    Date Received
    September 11, 1996
    Manufacturer
    MEDICAL ENGINEERING 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

    PT HAS SX'S SUGGESTIVE OF MILD INTERSTITIAL CYSTITIS, PERIPHERAL NEUROPATHY LT UE > RT UE, ANXIETY, DEPRESSION, ORGANIZATIONAL DIFFICULTY, LACK OF CONCENTRATION, SHORT-TERM MEMORY LOSS, MOOD SWINGS, PROCRASTINATION, GETTING LOST OR CONFUSED, DEMENTIA, BALANCE DISTURBANCES/VERTIGO/DIZZINESS, PAIN AND/OR BURNING SENSATION IN CHEST, INFLAMMATION OF CHEST/RIB CAGE, OCCASIONAL LOW GRADE FEVER (PT NL 97 - NOW 99 F). CHRONIC DIARRHEA AND/OR CONSTIPATION, IRRITABLE BOWEL SYNDROME, CHRONIC DISCHARGE, FREQUENT MIGRAINES SEVERE HEADACHES, CHEST PAINS W/NO FINDINGS, HYPERSENSITIVITY OR ALLERGIES TO CHEMICALS, INFLAMMATION, SWELLING, PAIN/ARTHRALGIA, PERSISTENT JOINT STIFFNESS, CHRONIC SWOLLEN LYMPH NODES/LYMPHADENOPATHY UNDER ARMS LT > RT, LYMPH NODES REMOVED LOCATION(S) ARM PIT, BX DONE, CHRONIC UNEXPLAINED MUSCLE SPASMS, MUSCLE PAIN AND BURNING, MUSCLE ATROPHY, FIBROMYALGIA, UNEXPLAINED RASHES, SUN SENSITIVITY, NON-RESTORATIVE SLEEP, CHRONIC FATIGUE SYNDROME, LONG-TERM EXTREME FATIGUE, GRANULOMAS OR SILICANOMAS, CLUMSINESS/DROPS THINGS, MISJUDGES DISTANCE/RUNS INTO OBJECTS, SICCA (CLINICALLY), NIGHT SWEATS, CHOKING SENSATION, EASY BRUISING AND TINNITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK DOUBLE LUMNE BREAST IMPLANT Implant DOUBLE LUMEN BREAST IMPLANT FTR MEDICAL ENGINEERING CORP. * 8388-80-K

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| R| S