BEUDAMED
    FDA Adverse Event Death Summary report: N

    SILASTIC(R) MAMMARY IMPLANT, ROUND, FP

    MDR report key: 38387 · Received September 13, 1996

    Report

    Report Number
    1816403-1996-00051
    Event Type
    Death
    Date Received
    September 13, 1996
    Date of Event
    January 28, 1992
    Report Date
    August 16, 1996
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    H3 - DEVICES WERE RETURNED TO DOW CORNING FOR ID PURPOSES ONLY AND RETURNED TO A FACILITY WITHOUT FURTHER EVALUATION.

    Additional Manufacturer Narrative · 1

    H3 - DEVICES WERE RETURNED TO DOW CORNING FOR ID PURPOSES ONLY AND RETURNED TO A FACILITY WITHOUT FURTHER EVALUATION.

    Description of Event or Problem · 1

    REPORT ALLEGES PATIETN RECEIVED IMPLANTS ON MARCH 31, 1977. PHYSICIAN'S CONSULTATION NOTES SHOW THAT PATIENT WAS HOSPITALIZED IN AUGUST 1987 FOR EVALUATION OF WEAKNESS AND A DIAGNOSIS OF MAJOR DEPRESSIVE EPISODES WAS MADE. SHE WAS ALSO HOSPITALIZED IN AUGUST 1988 FOR EVALUATION OF SEVERE EPIGASTRIC PAIN WHICH IS PROBABLY OF MUSCULAR ORIGIN. SHE HAS KNOWN DEGENERATIVE JOINT DISEASE OF THE CERVICAL SPINE AND HIP. CLINICAL NOTES OF OCT. 13, 1989 SHOWS PATIENT COMPLAINS OF PAIN OF HER RIGHT AND LEFT TEMPOROMANDIBULAR JOINT AND NOTES OF SEPT. 10, 1992 SHOW SHE HAS A PERSISTENT PRURITIC SPREADING RASH. PATIENT HAD REMOVAL AND REPLACEMENT OF BOTH IMPLANTS ON JAN. 28, 1993 WITH SALINE DEVICES OF ANOTHER MFR, DUE TO RUPTURE AND LEAKAGE.

    Description of Event or Problem · 1

    REPORT ALLEGES PATIENT RECEIVED IMPLANTS ON MARCH 31, 1977. PHYSICIAN'S CONSULTATION NOTES SHOW THAT PATIENT WAS HOSPITALIZED IN AUG. 1987 FOR EVALUATION OF WEAKNESS AND A DIAGNOSIS OF MAJOR DEPRESSIVE EPISODES WAS MADE. SHE WAS ALSO HOSPITALIZED IN AUG. 1988 FOR EVALUATION OF SEVERE EPIGASTRIC PAIN WHICH IS PROBABLY OF MUSCULAR ORIGIN. SHE HAS KNOWN DEGENERATIVE JOINT DISEASE OF THE CERVICAL SPINE AND HIP. CLINICAL NOTES OF OCT. 13, 1989 SHOWS PATIENT COMPLAINS OF PAIN OF HER RIGHT AND LEFT TEMPOROMANDIBULAR JOINT AND NOTES OF SEPT. 10, 1992 SHOW SHE HAS A PERSISTENT PRURITIC SPREADING RASH. PATIENT HAD REMOVAL AND REPLACEMENT OF BOTH IMPLANTS ON JAN. 28, 1993 WITH SALINE DEVICES OF ANOTHER MFR, DUE TO RUPTURE AND LEAKAGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| O| R