BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMOOTH ROUND MOD. PROFILE

    MDR report key: 12632540 · Received October 14, 2021

    Report

    Report Number
    1645337-2021-11389
    Event Type
    Injury
    Date Received
    October 14, 2021
    Date of Event
    September 28, 2021
    Report Date
    October 22, 2021
    Manufacturer
    MENTOR MEDICAL SYSTEM B.V.
    Product Code
    FTR
    UDI-DI
    00081317000327
    PMA / PMN Number
    P030053
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON OCTOBER 22, 2021, MENTOR RECEIVED THE DEVICE LOT NUMBER 5834281. LOT NUMBER 5834281 WAS CHECKED IN JDE AND IT WAS MANUFACTURED IN NETHERLANDS. CATALOG: 350-7400BC THE DEVICE REPORTED IN THIS COMPLAINT WAS MANUFACTURED IN LEIDEN, NETHERLANDS. HENCE, DOESN¿T MEET THE CRITERIA FOR MDR REPORTING AND THEREFORE THIS IS THE LAST REPORT THAT WILL BE SUBMITTED. THE LEIDEN BREAST IMPLANTS THAT ARE MANUFACTURED AND DISTRIBUTED UNDER THE MENTOR BRAND BUT ARE NOT APPROVED FOR IMPORT INTO THE UNITED STATES DO NOT MEET THE CRITERIA FOR MDR REPORTING AS A SAME OR SIMILAR DEVICE TO A DEVICE THAT IS MARKETED IN THE UNITED STATES. SPECIFICALLY, THE DEVICES DIFFER IN MANUFACTURING PROCESSES AND DEVICE SPECIFICATIONS. THEREFORE, EVENTS THAT INVOLVE THESE DEVICES WOULD NOT NEED TO BE REPORTED AS MDRS. MANUFACTURER'S SITE PHONE: (B)(4). MANUFACTURER'S SITE FAX: (B)(4). 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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: LEFT RUPTURE, AND CAPSULAR CONTRACTURE; BAKER GRADE III. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST AUGMENTATION WITH A 400CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT SIDE, AND WITH UNKNOWN SIZE UNKNOWN GEL IMPLANT ON THE RIGHT SIDE AND EXPERIENCED LEFT SIDE BREAST IMPLANT RUPTURE, AND BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH SIMILAR MENTOR PROSTHESIS ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1532207 SMOOTH ROUND MOD. PROFILE PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR MEDICAL SYSTEM B.V. 3504001BC 5834281 00081317000327

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention