BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND HIGH PROFILE

    MDR report key: 8390731 · Received March 5, 2019

    Report

    Report Number
    1645337-2019-08989
    Event Type
    Injury
    Date Received
    March 5, 2019
    Date of Event
    March 27, 2002
    Report Date
    February 11, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001584
    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) 2019, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: IT WAS INITIALLY REPORTED THAT THE DATE OF EVENT IS (B)(6) 2019. NEW INFORMATION STATES THAT THE DATE OF EVENT IS (B)(6) 2002. THE PATIENT AGE AT THE TIME OF EVENT IS 25 YEARS OLD. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEEN DISCARDED. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: MENTOR SMOOTH ROUND HIGH PROFILE 210CC SALINE BREAST PROSTHESIS, CATALOG #3503210, LOT #231322. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND HIGH PROFILE 210CC SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. THE PATIENT REPORTED THAT THE IMPLANT IN HER RIGHT BREAST WAS SLOWLY LEAKING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 300CC GEL BREAST PROSTHESES ON (B)(6) 2019. THE EXPLANTED DEVICES WERE DISCARDED AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185962 MENTOR SMOOTH ROUND HIGH PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 231322 00081317001584

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention