BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 11340436 · Received February 17, 2021

    Report

    Report Number
    1645337-2021-01633
    Event Type
    Injury
    Date Received
    February 17, 2021
    Date of Event
    May 31, 2011
    Report Date
    January 26, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE LEFT DEVICE IDENTITY IS CAT#:3501670, LOT#: 213380 AND RIGHT DEVICE CAT#: 3501670, LOT#: 251573, SN#: (B)(6). ON (B)(6) 2021: THE MANUFACTURING RECORD EVALUATION (MRE) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. DATE OF EVENT UPDATED TO (B)(6) 2011. THIS REPORT RELATES TO THE LEFT PROSTHESIS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: GENERALIZED ILLNESSES, DEFLATION. (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH TWO UNKNOWN MENTOR SALINE BREAST IMPLANTS HAS EXPERIENCED LEFT-SIDED IMPLANT DEFLATION, AND UNEXPLAINED SYSTEMIC SYMPTOMS POSTOPERATIVELY, INCLUDING SICK FOR YEARS. THE PATIENT REPORTED THAT THE IMPLANT BEGAN TO GET BIGGER AND ONE DAY IT WAS DEFLATED AND THAT SHE HAS BEEN FEELING BETTER EVER SINCE THE IMPLANTS HAVE BEEN REMOVED. AS A RESULT PATIENT HAD BOTH IMPLANTS REMOVED ON (B)(6) 2019. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236828 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention