BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX CONTOUR PROFILE MODERATE

    MDR report key: 10735381 · Received October 26, 2020

    Report

    Report Number
    1645337-2020-13657
    Event Type
    Injury
    Date Received
    October 26, 2020
    Date of Event
    September 10, 2020
    Report Date
    October 5, 2020
    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) 2020, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: THE DATE OF EVENT WAS REPORTED TO BE (B)(6) 2020. THE IMPLANTATION DATE WAS REPORTED TO BE (B)(6) 2003. THE SUSPECT MEDICAL DEVICE IS A MENTOR SILTEX CONTOUR PROFILE MODERATE 350CC SALINE BREAST PROSTHESIS, CATALOG #3542913, LOT #260730, SERIAL # (B)(6) , UDI # (B)(4), PMA #P990075. 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

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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 REVIEW COULD BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH AN UNSPECIFIED MENTOR SMOOTH SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. THE PATIENT NOTICED THE DEFLATION OF HER RIGHT BREAST PROSTHESIS AND WENT TO THE EMERGENCY ROOM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201858 MENTOR SILTEX CONTOUR PROFILE MODERATE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 260730

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other