BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT RESERVOIR

    MDR report key: 198252 · Received November 19, 1998

    Report

    Report Number
    198252
    Event Type
    Malfunction
    Date Received
    November 19, 1998
    Date of Event
    November 10, 1998
    Report Date
    November 18, 1998
    Manufacturer
    MENTOR H/S
    Product Code
    LCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LEFT BREAST IMPLANT RESERVOIR PLACED 2/23/1996. REMOVAL OF BREAST IMPLANTS ON 11/10/1998 DUE TO TIGHTNESS ACROSS HER CHEST, CHRONIC PAIN AND DISCOMFORT AND UNACCEPTABLE COSMETIC RESULT. SALINE FILLED TEXTURED IMPLANTS WITH A FILL OF 425 CC. CAPSULE SURROUNDING THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANT RESERVOIR Implant * LCJ MENTOR H/S * 95335

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR