BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEYER-SCHULTE

    MDR report key: 346436 · Received August 8, 2001

    Report

    Report Number
    MW1022601
    Event Type
    Injury
    Date Received
    August 8, 2001
    Date of Event
    January 29, 1979
    Report Date
    August 8, 2001
    Manufacturer
    HEYER-SCHULTE CORP SUB OF AMERICAN HOSP SUPPLY CORP
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HEYER-SCHULTE SALINE IMPLANTS WITH 20 MG OF SOLUMEDROL PLACED IN EACH IMPLANT. RPTR HAS BEEN SO SICK FOR THE LAST 20 YEARS. TODAY RPTR BELIEVES MORE THAN EVER THAT IT IS BECAUSE OF THE SALINE IMPLANTS THAT THEY HAVE INSIDE OF THEM. RPTR HAS HAD TONS OF NEUROLOGICAL PROBLEMS, INCLUDING BLURRED AND DOUBLE VISION, MEMORY LOSS, NUMBNESS, TINGLING, BURNING, ITCHING, DRY EYES AND DRY MOUTH, SLURRED SPEECH, DIFFICULTY PROCESSING INFORMATION, LOSS OF BALANCE, AND THE LIST GOES ON AND ON. MS TYPE SYMPTOMS, CHRONIC FATIGUE, AND PAIN, PERIPHERAL NEUROPATHY, TIA-TYPE SYMPTOMS, HEADACHES, FLU-LIKE SYMPTOMS ALL OF THE TIME. RPTR IS WORKING ON HAVING THESE TOXIC THINGS REMOVED FROM BODY. AFTER THE PATH DEPT HERE EXAMINES THEM RPTR WILL SEND THEM FOR DR TO DO REPORT. THE FDA IS WELCOME TO THEM AFTER THAT BUT RPTR WANTS THEM BACK WHEN EVERYONE IS FINISHED WITH THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35869 HEYER-SCHULTE BREAST IMPLANT ROUND 175 NS + 20MG FWM HEYER-SCHULTE CORP SUB OF AMERICAN HOSP SUPPLY CORP 1620 -175CC- 170603
    35870 HEYER-SCHULTE BREAST IMPLANT ROUND 250 NS + 20MG FWM HEYER-SCHULTE CORP SUB. OF AMERICAN HOSPITAL SUPPLY CORP. 1630 -250CC- 171646

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Disability