BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SALINE IMPLANTS

    MDR report key: 12344355 · Received August 19, 2021

    Report

    Report Number
    1645337-2021-09361
    Event Type
    Injury
    Date Received
    August 19, 2021
    Date of Event
    January 1, 2017
    Report Date
    July 23, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: BREAST ASYMMETRY, WRINKLING, RIPPLING, CAPSULAR CONTRACTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT, WHO'S UNDERGONE PRIMARY BREAST AUGMENTATION WITH AN UNSPECIFIED MENTOR SALINE BREAST PROSTHESIS ON THE RIGHT BREAST, SUFFERED BREAST ASYMMETRY, WRINKLING, RIPPLING, SMALLER THAN DESIRED BREAST, AND CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN), POST-PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH THE FOLLOWING DEVICES ON (B)(6) 2017: (LEFT) 475CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3504751BC LOT: 7002024 SN: (B)(4) AND (RIGHT) 475CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3504751BC LOT: 7377876 SN: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237971 UNKNOWN SALINE IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention