BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM MOD CLASSIC GEL, 215CC

    MDR report key: 11311694 · Received February 10, 2021

    Report

    Report Number
    1645337-2021-01410
    Event Type
    Injury
    Date Received
    February 10, 2021
    Date of Event
    January 1, 2014
    Report Date
    January 14, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317004103
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 17-FEB-2021, MENTOR RECEIVED ADDITIONAL INFORMATION REGARDING THE PATIENT'S SYMPTOMS. THE PATIENT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, IT WAS FOUND THAT THE MRE STATEMENT WAS OMITTED ON THE PREVIOUS REPORT. MANUFACTURER'S REFERENCE NUMBER: (B)(4), 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.

    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 IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: UNKNOWN. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES (RIGHT: 235CC, LEFT: 215CC) POSTOPERATIVELY EXPERIENCED RIGHT-SIDED CAPSULAR CONTRACTURE (GRADE UNKNOWN) AND DEVICE MIGRATION, AND LEFT-SIDED MEDICAL DEVICE REMOVAL DUE TO UNKNOWN REASONS. THE PATIENT NOTICED A LUMP IN (B)(6) 2014, AND THE PATIENT¿S IMPLANTING SURGEON INDICATED THAT THE RIGHT-SIDED DEVICE WAS BREAKING THROUGH THE BREAST TISSUE. AS A RESULT, THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2014. DURING THE SURGERY, THE LEFT-SIDED DEVICE WAS REPLACED WITH A 215CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG #: 3507215MC, SERIAL #:6833268-012) FOR UNKNOWN REASONS, AND THE RIGHT-SIDED DEVICE WAS REMOVED, WASHED, AND RE-IMPLANTED. THE PATIENT STATED THAT BIOPSY PERFORMED ON UNSPECIFIED DATE INDICATED THAT THE RIGHT-SIDED LUMP FOUND IN 2014 WAS CALCIFICATION FROM THE PRIMARY BREAST AUGMENTATION SURGERY. SOMETIME IN 2015, THE PATIENT EXPERIENCED RIGHT-SIDED CAPSULAR CONTRACTURE (UNKNOWN GRADE). THE PATIENT CURRENTLY EXPERIENCES RIGHT-SIDED BREAST DEFORMITY AND BREAST PAIN. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2021. THE DATE OF EVENT WAS ESTIMATED AS (B)(6) 2014 BASED ON AVAILABLE INFORMATION. BREAST IMPLANTS ARE INTENDED FOR SINGLE USE ONLY. RE-USE INCLUDES A RISK OF INFECTION (MICROBIAL AS WELL AS VIRUSES AND TRANSMISSIBLE AGENTS) AS WELL AS IMMUNE RESPONSES. THE STERILITY OF THE DEVICE CAN NO LONGER BE GUARANTEED. FURTHERMORE, THE INTEGRITY OF THE DEVICE CANNOT BE GUARANTEED DUE TO THE RISK OF DAMAGE TO THE DEVICE. THIS REPORT IS FOR THE LEFT-SIDED PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205846 SM MOD CLASSIC GEL, 215CC PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3507215MC 6525532 00081317004103

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention