BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 10623832 · Received October 2, 2020

    Report

    Report Number
    1645337-2020-12491
    Event Type
    Injury
    Date Received
    October 2, 2020
    Date of Event
    April 30, 2008
    Report Date
    September 8, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001386
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ON (B)(6) 2020, MENTOR BECAME AWARE OF THE DATE OF EVENT AND THAT THE PATIENT ALSO EXPERIENCE DIFFICULTY CONCENTRATING, MEMORY LOSS, MOOD SWINGS, SHARP BREAST PAIN AND FACET JOINT SYNDROME. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE REMOVAL ON AN UNSPECIFIED DATE. SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: GENERALIZED ILLNESS. THIS REPORT IS FOR THE PATIENT'S LEFT-SIDED DEVICE. MANUFACTURER'S REFERENCEC NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: N/A. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH 275CC SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE BREAST IMPLANTS AND EXPERIENCED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING PAINFUL NIPPLE SENSITIVITY, BACK PAIN, SHOULDER BLADE PAIN, NECK PAIN, EYE PAIN, MIGRAINE HEADACHES, BREAST SPASMS, ARM TINGLING/ NUMB, ANXIETY, DEPRESSION, INSOMNIA, FATIGUE, JOINT PAIN, BRAIN FOG, VERTIGO, HEART PALPITATIONS, BODY INFLAMMATION AND DECREASED LIBIDO. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE PATIENT'S LEFT-SIDED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087398 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3502275 5803180 00081317001386

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other| R