BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC VARIFIL MAMMARY IMPLANT, H.P., INFLATABLE

    MDR report key: 46570 · Received October 31, 1996

    Report

    Report Number
    1816403-1996-00227
    Event Type
    Injury
    Date Received
    October 31, 1996
    Date of Event
    August 1, 1996
    Report Date
    October 3, 1996
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: 86C DIMENSIONAL MEASUREMENT; 86D MICROSCOPIC EXAMINATION. RESULTS: 100A LOSS OF SHELL INTEGRITY, ENVELOPE SLIT; 100B CREASE LINES; 100C SLIGHT AMBER COLOR; 100E FOREIGN MATERIAL; 100H LOSS OF SHELL INTEGRITY, EVELOPE TEAR. DEVICE 1 OF 2 CONCLUSIONS: 68 FOREIGN MATERIAL LIKELY RESIDUAL SALINE; SLIT CAUSED BY SHARP OBJECT CONTACT; COLOR WITHIN SPECIFICATIONS; CREASES AND WEAR RESULT OF FOLDING ACTION IN-VIVO. DEVICE 2 OF 2 CONCLUSIONS: 68 FOREIGN MATERIAL LIKELY RESIDUAL SALINE; CAUSE OF TEAR UNDETERMINED; COLOR WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    METHOD: 86C DIMENSIONAL MEASUREMENT; 86D MICROSCOPIC EXAMINATION. RESULTS: 100A LOSS OF SHELL INTEGRITY, ENVELOPE SLIT; 100B CREASE LINES; 100C SLIGHT AMBER COLOR; 100E FOREIGN MATERIAL; 100H LOSS OF SHELL INTEGRITY, ENVELOP TEAR. DEVICE 1 OF 2 CONCLUSIONS: 68 FOREIGN MATERIAL LIKELY RESIDUAL SALINE; SLIT CAUSED BY SHARP OBJECT CONTACT; COLOR WITHIN SPECIFICATIONS; CREASES AND WEAR RESULT OF FOLDING ACTION IN-VIVO. DEVICE 2 OF 2 CONCLUSIONS: 68 FOREIGN MATERIAL LIKELY RESIDUAL SALINE; CAUSE OF TEAR UNDETERMINED; COLOR WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    PHYSICIAN'S NOTE SHOWS PT RECEIVED BREAST IMPLANTS ON 5/16/79. IN 8/95, PT HAD DEFLATION OF LEFT IMPLANT; THERFORE, ON 9/4/96 PT HAD EXCISION OF THE DEFLATED LEFT AND INTACT RIGHT IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC VARIFIL MAMMARY IMPLANT, H.P., INFLATABLE Implant MAMMARY IMPLANT, SALINE FILL FWM DOW CORNING CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention