BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLERGAN NATRELLE SILICONE 20-800 SILICONE BREAST IMPLOANT L & R

    MDR report key: 8838132 · Received July 26, 2019

    Report

    Report Number
    MW5088437
    Event Type
    Injury
    Date Received
    July 26, 2019
    Date of Event
    August 24, 2018
    Report Date
    July 24, 2019
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PAIN AND SWELLING IN LEFT BREAST, PAIN IN RIGHT BREAST AFTER MAMMOGRAM, ALSO LUMPS AND DIMPLES IN BOTH BREAST. I HAVE ALLERGAN 20-800 SILICONE BREAST IMPLANTS. SURGERY DATE: (B)(6) 2018. MAMMOGRAM AND OTHERS SAID CANCER DOESN'T CAUSE PAIN. OTHER UNEXPLAINED HEALTH CONDITIONS; CAPSULARY CONTRACTURE WITH BREAST DISTORTION AND SEVERE PAIN. BELIEVED I WAS GOING INTO EARLY MENOPAUSE. A ONE VIEW ASYMMETRY IS IDENTIFIED IN THE UPPER LEFT BREAST, ON THE IMPLANT DISPLACED MLO VIEW, MIDDLE DEPTH 6 CM FROM THE NIPPLE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624269 ALLERGAN NATRELLE SILICONE 20-800 SILICONE BREAST IMPLOANT L & R PROSTHESIS, BREAST, NON-INFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN 20-800 UNK
    624340 ALLERGAN NATRELLE SILICONE 20-800 SILICONE BREAST IMPLOANT L & R PROSTHESIS, BREAST, NON-INFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN 20-800 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention| S