BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC MAMMARY IMPLANT, CONTOUR, FP

    MDR report key: 43683 · Received October 18, 1996

    Report

    Report Number
    1816403-1996-00100
    Event Type
    Injury
    Date Received
    October 18, 1996
    Date of Event
    September 9, 1996
    Report Date
    September 20, 1996
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: 86B WEIGHT MEASUREMENT. RESULTS: 100C SLIGHT AMBER COLOR; 100E FOREIGN MATERIAL; 100G CLOUDY; 100H LOSS OF SHELL INTEGRITY, ENVELOPE TEAR; 100I WEIGHT LOSS THAN SPECIFIED. DEVICE 1 OF 2 CONCLUSION: 68 CAUSE OF TEAR(S) UNDETERMINED; FOREIGN MATERIAL CAUSE AND SOURCE UNDETERMINED; CAUSE OF CLOUDINESS UNDETERMINED; GEL NOT ALL RETURNED. DEVICE 2 OF 2 CONCLUSION: 68 CAUSE OF TEAR(S) UNDETERMINED; FOREIGN MATERIAL CAUSE AND SOURCE UNDETERMINED; CAUSE OF CLOUDINESS UNDETERMINED; WEIGHT WITHIN SPECIFICATION LIMITS.

    Additional Manufacturer Narrative · 1

    METHOD: 86B WEIGHT MEASUREMENT. RESULTS: 100C SLIGHT AMBER COLOR; 100E FOREIGN MATERIAL; 100G CLOUDY; 100H LOSS OF SHELL INTEGRITY, ENVELOPE TEAR; 100I WEIGHT LESS THAN SPECIFIED. DEVICE 1 OF 2 CONCLUSION: 68 CAUSE OF TEAR(S) UNDETERMINED; FOREIGN MATERIAL CAUSE AND SOURCE UNDETERMINED; CAUSE OF CLOUDINESS UNDETERMINED; GEL NOT ALL RETURNED. DEVICE 2 OF 2 CONCLUSION: 68 CAUSE OF TEAR(S) UNDETERMINED; FOREIGN MATERIAL CAUSE AND SOURCE UNDETERMINED; CAUSE OF CLOUDINESS UNDETERMINED; WEIGHT WITHIN SPECIFICATION LIMITS.

    Description of Event or Problem · 1

    REPORT ALLEGES PT RECEIVED BREAST IMPLANTS ON 11/21/78. REPORT ALSO ALLEGES THE PT'S IMPLANTS WERE RUPTURED; THEREFORE, SHE HAD REMOVAL ON 9/9/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC MAMMARY IMPLANT, CONTOUR, FP Implant MAMMARY IMPLANT, GEL-FILLED FTR DOW CORNING CORP. NA HH3659

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention