BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX CONTOUR PROFILE

    MDR report key: 7740231 · Received August 1, 2018

    Report

    Report Number
    1645337-2018-04675
    Event Type
    Injury
    Date Received
    August 1, 2018
    Date of Event
    July 11, 2018
    Report Date
    July 11, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 11/14/2018, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE COMPLAINT DEVICE. AS A RESULT, THE MANUFACTURING DATE AND EXPIRATION DATE FIELDS HAVE BEEN UPDATED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2018, MENTOR BECAME AWARE THAT THE SUSPECT MEDICAL DEVICE WAS MENTOR SILTEX CONTOUR PROFILE HIGH 350CC SALINE CATALOG: 3542712, LOT: 151022. MENTOR ALSO BECAME AWARE THAT THE CONCOMITANT DEVICE WAS MENTOR SILTEX CONTOUR PROFILE HIGH 350CC SALINE CATALOG: 3542712, LOT: 153164. (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 DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH AN UNKNOWN SALINE BREAST PROSTHESIS. DEFLATION OF THE LEFT BREAST PROSTHESIS WAS IDENTIFIED. 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
    582264 MENTOR SILTEX CONTOUR PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 151022

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other