BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 8611927 · Received May 15, 2019

    Report

    Report Number
    1645337-2019-11852
    Event Type
    Injury
    Date Received
    May 15, 2019
    Date of Event
    March 3, 2000
    Report Date
    April 15, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001201
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    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: AUTOIMMUNE DISORDER. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED (VIA FDA MW5084639) THAT A FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED PROCEDURE WITH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 200CC BREAST IMPLANTS STARTED EXPERIENCING PAIN AND SWELLING IN HER HANDS AND FEET A FEW MONTHS POST IMPLANTATION. SHE WAS DIAGNOSED IN 2000 WITH RHEUMATOID ARTHRITIS. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 200CC, CATALOG NUMBER 3501625, LOT NUMBER 241872 (L) AND 243383 (R) ON (B)(6) 2002. NO PRODUCT MALFUNCTION, SUCH AS DEFLATION, WAS REPORTED. THE ROOT CAUSE OF THE PATIENT'S SYMPTOMS ARE UNCLEAR. THIS REPORT IS FOR THE SECOND OF TWO DEVICES RELATED TO THIS EVENT. SEE MEDWATCH REPORT 1645337-2019-11853 FOR CONTRALATERAL SIDE. THE LOT NUMBERS AND ASSOCIATED DATES OF IMPLANTS PROVIDED IN MW5084639 ARE NOT IN LINE WITH THE MANUFACTURING DATES OF THE REPORTED COMPLAINT DEVICES. AS A RESULT, THIS REPORT INCLUDES THE LOT NUMBER MOST LIKELY PERTAINING TO THE DATE OF IMPLANT SPECIFIED FOR THIS EVENT IN MW5084639. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SEE MEDWATCH REPORTS 1645337-2019-11859, 1645337-2019-11860, AND 1645337-2019-11863 FOR THE ADDITIONAL EVENTS RELATED TO THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404396 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 00081317001201

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention