BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC MAMMARY IMPLANT

    MDR report key: 174529 · Received June 26, 1998

    Report

    Report Number
    1816403-1998-00295
    Event Type
    Injury
    Date Received
    June 26, 1998
    Date of Event
    May 29, 1998
    Report Date
    May 29, 1998
    Manufacturer
    DOW CORNING CORPORATION
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: AMBER COLOR CONDITION OF AGING. CLOUDINESS CAUSE UNDETERMINED. CAUSE OF TEAR(S) UNDETREMINED. GEL NOT ALL RETURNED. FOREIGN MATERIAL CAUSE AND SOURCE UNDETERMINED. WEIGHT WITHIN SPECIFICATION LIMITS. TEAR(S) CAUSED BY STRESS. ENVELOPE THICKNESS WITHIN SPECIFICATION LIMITS. WEIGHT LOW DUE TO GEL MISSING.

    Description of Event or Problem · 1

    GRADE IV CAPSULAR. BILATERAL RUPTURED SILICONE IMPLANTS REMOVED, REPLACED WITH BILATERAL SALINE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC MAMMARY IMPLANT Implant MAMMARY IMPLANT, GEL-FILLED FTR DOW CORNING CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other| R