BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 8956011 · Received September 3, 2019

    Report

    Report Number
    1645337-2019-18275
    Event Type
    Injury
    Date Received
    September 3, 2019
    Date of Event
    October 1, 2005
    Report Date
    August 5, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001225
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 9/3/2019, IT WAS NOTICED THAT INITIAL REPORTER COUNTRY CODE WAS ERRONEOUSLY LEFT BLANK IN THE INITIAL REPORT SUBMITTED ON 9/3/2019. MANUFACTURER¿S REFERENCE 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: THE PATIENT HAS NOT UNDERGONE EXPLANTATION OR REOPERATION AT THIS TIME. CONCOMITANT MEDICAL PRODUCTS: SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 250CC, CATALOG NUMBER 3501635, LOT NUMBER 212140. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 250CC BREAST IMPLANT AND EXPERIENCED BREAST PAIN ON THE RIGHT SIDE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751804 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 211426 00081317001225

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other