BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 11275576 · Received February 3, 2021

    Report

    Report Number
    1645337-2021-01067
    Event Type
    Injury
    Date Received
    February 3, 2021
    Report Date
    January 14, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001232
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. 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: RIGHT SIDE IMPAIRED HEALING, DEVICE MIGRATION, AND HYPERTROPHIC SCAR MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 275CC MENTOR SMOOTH ROUND MODERATE PROFILE ON BOTH SIDES AND EXPERIENCED RIGHT SIDE IMPAIRED HEALING, A SMALL MASS ON THE RIGHT SIDE AND SLIGHT CLOSED CAPSULOTOMY WAS DONE TO RESOLVE THE ISSUE, RIGHT SIDE DEVICE MIGRATION, AND BILATERAL HYPERTROPHIC SCAR. THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT CATALOG NUMBER 3542660; LOT NUMBER 51897 ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3542660; LOT NUMBER 49713 ON THE RIGHT SIDE ON MARCH 14, 1991. THE SCARRING WAS THE PRIMARY REASON FOR IMPLANT BILATERAL REMOVAL AND REPLACEMENT. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172715 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3501640 20710 00081317001232

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention