BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTEX SALINE-FILLED MAMMORY PROSTHESIS

    MDR report key: 25940 · Received July 27, 1995

    Report

    Report Number
    25940
    Event Type
    Injury
    Date Received
    July 27, 1995
    Date of Event
    January 16, 1995
    Report Date
    February 10, 1995
    Manufacturer
    MENTOR
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    SIXTY-TWO YR OLD FEMALE HAD SILICONE IMPLANTS REMOVED 1/4/95 & CO SALINE IMPLANTS PLACED. ON 1/16/95, HAD SALINE IMPLANTS REMOVED DUE TO RUPTURE OF RIGHT IMPLANT & GRADE C PTOSIS.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILTEX SALINE-FILLED MAMMORY PROSTHESIS Implant SALINE BREAST IMPLANT FWM MENTOR (R) 70245 (L) 70351

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other