BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9836998 · Received March 16, 2020

    Report

    Report Number
    1645337-2020-04246
    Event Type
    Injury
    Date Received
    March 16, 2020
    Date of Event
    February 25, 2020
    Report Date
    February 27, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000112
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, PHOTO EVALUATION WAS COMPLETED. UPON VISUAL EVALUATION OF THE IMAGE PROVIDED IN THE COMPLAINT, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED ON THE IMAGE. ADDITIONALLY IN A PHOTO THE IMPLANT WAS OBSERVED COVERED WITH SCAR TISSUE. MENTOR CONCLUDED THAT THE CAPSULAR CONTRACTURE IN THE PATIENT´S BREAST WAS THE RESULT OF THE BODY´S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. CAPSULAR CONTRACTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. THE AMERICAN SOCIETY OF PLASTIC SURGEONS RECOMMENDS AND ENCOURAGES MEMBER SURGEONS TO ALWAYS SUBMIT BREAST IMPLANTS, CAPSULE, AND EFFUSION TO PATHOLOGY FOR EXAMINATION. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR LOT NUMBER 5960358, 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. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THIS SUPPLEMENTAL REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEEN DISCARDED. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE; BAKER GRADE IV. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT OF AN UNKNOWN AGE AND ETHNICITY UNDERWENT REVISION BREAST AUGMENTATION WITH 350CC MENTOR MEMORYGEL, BREAST IMPLANTS ON BOTH SIDES AND WAS PRESENTED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE IV AND RIGHT SIDE RUPTURE UPON EXPLANTATION ON (B)(6) 2020. THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER 3504001BC; SERIAL NUMBER (B)(4) ON THE LEFT SIDE AND WITH CATALOG NUMBER 3504001BC; SERIAL NUMBER (B)(4) ON THE RIGHT SIDE ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300676 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3507350BC 5960358 00081317000112

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention