BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 9639696 · Received January 28, 2020

    Report

    Report Number
    1645337-2020-01451
    Event Type
    Injury
    Date Received
    January 28, 2020
    Date of Event
    December 16, 2019
    Report Date
    January 7, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001775
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 2/19/2020, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE INVESTIGATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON 03/02/2020. DEVICE EVALUATION SUMMARY: ACCORDING TO THE REPORTED INFORMATION, THE PATIENT EXPERIENCED A DEFLATION IN THE BREAST IMPLANT. THE ANALYSIS RESULTS SHOW THAT THE DEVICE APPEARED INTACT. LEAK TESTING REVEALED THERE WAS LEAKAGE FROM THE VALVE. THE ANALYSIS WAS UNABLE TO DETERMINE THE ROOT CAUSE FOR THE LEAKING VALVE. EXCESSIVE MANIPULATION MAY HAVE CAUSED THE VALVE LEAK. THE IFU STATES ¿NOT TO MANIPULATE (I.E., SQUEEZE) THE VALVE EXCESSIVELY, WHICH MAY CAUSE VALVE LEAKAGE¿. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. 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

    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 IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. CONCOMITANT MEDICAL PRODUCTS: 275CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT CATALOG: 3542640 LOT:173968 SERIAL NUMBER: UNKNOWN. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH A 275CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101129 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3542640 192198 00081317001775

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention