BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEYER-SCHULTE SALINE BREAST IMPLANT

    MDR report key: 13415 · Received May 19, 1994

    Report

    Report Number
    MW1002113
    Event Type
    Injury
    Date Received
    May 19, 1994
    Date of Event
    May 14, 1974
    Report Date
    May 16, 1994
    Manufacturer
    MENTOR CORP.
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAS HAD CAPSULAR CONTRACTURE 7 TIMES, HAS HAD TO HAVE HER BREASTS "SQUEEZED" AND THEN HER IMPLANTS REPLACED. SHE ALSO COMPLAINS OF ALLERGIES, HEADACHES, FATIGUE, MUSCLE WEAKNESS, NUMBNESS OF HER HANDS, 7 SURGERIES AND NEEDS ONE MORE, BACK AND JOINT PAIN, HIVES, RASHES MUSCLE SPASMS, NAUSEA, DEPRESSION AND SINUS PROBLEMS. SHE STATES THAT SHE IS 45 AND FEELS LIKE 70. SHE HAS BEEN TO SEE NUMEROUS DDOCTORS INCLUDING A CHIROPRACTOR, ALLERGIST, EAR, NOSE AND THROAT SPECIALIST, PLASTIC SURGEONS, AND GYNECOLOGIST. (SAME RPTR REFERRED TO IN 1002111 1002112 AND 1002110.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER-SCHULTE SALINE BREAST IMPLANT Implant SALINE IMPLANT FWM MENTOR CORP. 44789

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention| S