BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTICAL (R) MAMMARY PROSTHESIS

    MDR report key: 42216 · Received October 11, 1996

    Report

    Report Number
    1816403-1996-00140
    Event Type
    Injury
    Date Received
    October 11, 1996
    Date of Event
    September 11, 1996
    Report Date
    September 12, 1996
    Manufacturer
    DOW CORNING CORP
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: 86B WEIGHT MEASUREMENT. RESULTS: 100 WEIGHT PACKAGING AND DEVICE; 100C SLIGHT AMBER COLOR; 100H LOSS OF SHELL INTEGRITY, ENVELOPE TEAR; 100G CLOUDY; 100J FOREIGN MATERIAL IN GEL; 100K AMBER COLOR. DEVICE 1 OF 2 CONCLUSIONS: 68 NO RESULTS SUPPORTED THE ALLEGED REASON OF "LUMP(S)"; AMBER COLOR CONDITION OF AGING; CLOUDINESS CAUSE UNDETERMINED. DEVICE 2 OF 2 CONCLUSIONS: 68 NO RESULT SUPPORTED THE ALLEGED REASON OF "DISFIGURED APPEARNACE"; COLOR WITHIN SPECIFICATION; CAUSE OF TEAR(S) UNDETERMINED; FOREIGN MATERIAL CAUSE AND SOURCE UNDETERMINED.

    Description of Event or Problem · 1

    PT RECEIVED IMPLANTS IN AUGUST 1975. REPORTER ALSO ALLEGES THAT PT'S IMPLANTS HAD A PIN HOLE AND WERE LEAKING; THEREFORE, SHE HAD REMOVAL ON SEPT. 11, 1996.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention