BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND SPECTRUM

    MDR report key: 8562687 · Received April 29, 2019

    Report

    Report Number
    1645337-2019-10655
    Event Type
    Injury
    Date Received
    April 29, 2019
    Date of Event
    July 1, 2018
    Report Date
    April 2, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317002086
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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: TRAUMATIC INJURY UNRELATED TO DEVICE, DEFLATION. CONCOMITANT PRODUCTS: 275CC MENTOR SILTEX ROUND SPECTRUM SALINE CATALOG: 3542440M, LOT: 6881306, SN: (B)(4). 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 WITH TWO 275CC MENTOR SILTEX ROUND SPECTRUM SALINE BREAST PROSTHESES, EXPERIENCED RIGHT SIDE DEFLATION CAUSED BY AN UNSPECIFIED ACCIDENT POST-OPERATIVELY. AS A RESULT, THE PATIENT WAS SCHEDULED FOR REMOVAL ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354655 MENTOR SILTEX ROUND SPECTRUM PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6881306 00081317002086

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention