BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTEX ROUND MOD. PLUS PROFILE

    MDR report key: 12953498 · Received December 7, 2021

    Report

    Report Number
    1645337-2021-13555
    Event Type
    Injury
    Date Received
    December 7, 2021
    Report Date
    November 17, 2021
    Manufacturer
    MENTOR MEDICAL SYSTEM B.V.
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON FEB 25 2022, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE DEVICE (LOT 6003545) WAS FOUND TO BE MANUFACTURED BY MENTOR MEDICAL SYSTEMS B.V. MENTOR MEDICAL SYSTEMS B.V, LOCATED IN LEIDEN, THE NETHERLANDS, IS A FOREIGN MANUFACTURER OF MEDICAL DEVICES THAT ARE NOT CLEARED OR APPROVED FOR SALE IN THE US. AS A RESULT, NO FURTHER INVESTIGATION WILL TAKE PLACE OR REPORTS SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST IMPLANTATION PROCEDURE WITH AN UNSPECIFIED MENTOR GEL BREAST IMPLANT AND EXPERIENCED RUPTURE (SIDE UNKNOWN) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR GEL BREAST IMPLANTS (SERIAL NUMBERS (B)(4)) ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1844901 SILTEX ROUND MOD. PLUS PROFILE PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR MEDICAL SYSTEM B.V. 6003545

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention