BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC (R) II MAMMARY IMPLANT, H.P. HPR

    MDR report key: 41474 · Received October 3, 1996

    Report

    Report Number
    1816403-1996-00118
    Event Type
    Injury
    Date Received
    October 3, 1996
    Date of Event
    April 1, 1994
    Report Date
    September 6, 1996
    Manufacturer
    DOW CORNING CORP
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPORT STATES PT RECEIVED A LEFT IMPLANT AUG 27, 1990. REPORT ALSO STATES PT'S SYMPTOMS WERE OBVIOUS BY APRIL, 1994 AND SHE WAS DIAGNOSED IN NOV, 1994 WITH ACQUIRED CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULAR NEUROPATHY AND SEVERE SENSORY MOTOR AND AUTONOMIC NERVE DAMAGE. PT HAD REMOVAL IN AUG, 1994 OR ON AUG 24, 1996. REFERENCE MEDWATCH 1009777.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC (R) II MAMMARY IMPLANT, H.P. HPR Implant MAMMARY IMPLANT, GEL-FILLED FTR DOW CORNING CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L| O| R| S