BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7643062 · Received June 27, 2018

    Report

    Report Number
    1645337-2018-03917
    Event Type
    Injury
    Date Received
    June 27, 2018
    Date of Event
    January 1, 2003
    Report Date
    June 4, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001270
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 8/30/2018, MENTOR BECAME AWARE THAT PATIENT CODE CALCIFICATION WAS ERRONEOUSLY OMITTED FROM THE INITIAL REPORT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2018, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE COMPLAINT DEVICE. AS A RESULT, THE MANUFACTURING DATE AND EXPIRATION DATE FIELDS HAVE BEEN UPDATED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. 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. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: MENTOR SMOOTH ROUND MODERATE PROFILE 375CC SALINE, CATALOG: 3501660, LOT: 240590. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WITH MENTOR SMOOTH ROUND MODERATE PROFILE 375CC SALINE BREAST PROSTHESES. IT WAS REPORTED THAT THE PATIENT WAS CONCERNED THAT THE PROSTHESES CONTRIBUTED TO HER FOLLOWING HEALTH ISSUES: BREAST PAIN, CHEST PAIN, BREAST CALCIFICATION, FEELING COLD, HAIR DOES NOT GROW, DRY SKIN, VISION ISSUES, DEPRESSION, ANXIETY, INSOMNIA, CAN'T GAIN WEIGHT, NUMBNESS DOWN ARM, SHORT STABBING PAIN ON LEFT NIPPLE AND BRAIN FOG. IT WAS ALSO REPORTED THAT THE PATIENT STARTED EXPERIENCING SYMPTOMS WITHIN A YEAR OF THE IMPLANTATION DATE OF (B)(6) 2002. AS A RESULT, THE PATIENT WAS SCHEDULED FOR EXPLANTATION ON (B)(6) 2019. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485930 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 240590 00081317001270

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention