BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC II MAMMARY IMPLANT, H.P. LPR

    MDR report key: 169638 · Received May 27, 1998

    Report

    Report Number
    1816403-1998-00236
    Event Type
    Injury
    Date Received
    May 27, 1998
    Date of Event
    April 23, 1998
    Report Date
    April 29, 1998
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    D7 - ORIGINAL CALL REPORT SHOWS PATIENT RECEIVED HER IMPLANT ON MARCH 4, 1991; HOWEVER, THE USER FACILITY REPORT STATES THE IMPLANT DATE WAS APRIL 3, 1991. METHODS: WEIGHT MEASUREMENT. RESULTS: SLIGHT AMBER COLOR. VOIDS IN GEL. WEIGHT MEASUREMENT. INTACT WITH FULL SHELL INTEGRITY. CONCLUSIONS: COLOR WITHIN SPECIFICATIONS. WEIGHT WITHIN SPECIFICATION LIMITS.

    Description of Event or Problem · 1

    REPORTER ALLEGES THE PT HAD PAIN AND A TRANSFLAP WAS PERFORMED. EXPLANTATION OF LEFT BREAST DUE TO PAIN. IT APPEARS THE PT HAD CAPSULAR CONTRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC II MAMMARY IMPLANT, H.P. LPR Implant MAMMARY IMPLANT, GEL-FILLED FTR DOW CORNING CORP. NA HH096409

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| O