BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 14365871 · Received May 11, 2022

    Report

    Report Number
    1645337-2022-05504
    Event Type
    Injury
    Date Received
    May 11, 2022
    Date of Event
    March 1, 2022
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317006985
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE HAS BEEN DISCARDED. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RIGHT BREAST PROSTHESIS RUPTURE, BILATERAL BREAST PTOSIS. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. THE SUSPECT MEDICAL DEVICE IS A MENTOR MEMORYGEL BREAST IMPLANT 535CC GEL BREAST PROSTHESIS, CATALOG #3505535BC, LOT #6866828, SERIAL #(B)(6) UDI #(B)(4) PMA #P030053. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH AN UNSPECIFIED MENTOR GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BREAST IMPLANT 535CC GEL BREAST PROSTHESIS (RIGHT DEVICE) WHEN THE RIGHT BREAST PROSTHESIS RUPTURED POST IMPLANTATION. THE RUPTURE WAS DIAGNOSED VIA MRI. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BREAST PTOSIS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 375CC SALINE BREAST PROSTHESES ON (B)(6) 2022. THE REMOVED BREAST PROSTHESES WERE DISCARDED FOLLOWING EXPLANT SURGERY. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2130906 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3505535BC 6866828 00081317006985

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention