BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILASTIC II

    MDR report key: 4426 · Received July 22, 1992

    Report

    Report Number
    4426
    Event Type
    Malfunction
    Date Received
    July 22, 1992
    Date of Event
    May 11, 1992
    Report Date
    May 27, 1992
    Manufacturer
    DOW CORNING WRIGHT
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DOW CORNING SILASTIC II IMPLANTS WERE EXPLANTED ON MAY 11, 1992. THE LEFT IMPLANT WAS INTACT WITH MINIMAL TO NO GEL BLOOD. THE RIGHT IMPLANT HAD A SINGLE 2 MM. LEAK ALONG THE MEDIAL ASPECT. THERE WAS NO DETECTABLE SILICONE OUTSIDE OF CAPSULE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC II Implant BREAST IMPLANT FTR DOW CORNING WRIGHT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other