BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9622861 · Received January 23, 2020

    Report

    Report Number
    1645337-2020-01194
    Event Type
    Injury
    Date Received
    January 23, 2020
    Date of Event
    December 31, 2019
    Report Date
    January 3, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000532
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 2/7/2020, THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. THE INVESTIGATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON 2/18/2020. DEVICE EVALUATION SUMMARY: ACCORDING TO THE REPORTED INFORMATION, THE DOCTOR DISCOVERED AT TIME OF SURGERY A FAILED VALVE ON A SALINE IMPLANT. DURING VISUAL EVALUATION, THE SAMPLE WERE OBSERVED TEAR IN THE ANTERIOR ASPECT. LEAK TEST WAS PERFORMED AND THE VALVE WAS OBSERVED IN GOOD CONDITION. MICROSCOPIC EXAMINATION OF THE EDGES OF THE TEAR GAVE NO INDICATIONS OF INSTRUMENT DAMAGE. NO OTHER ANOMALIES OBSERVED. 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. DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH MENTOR MAMMARY PROSTHESES. POSSIBLE CAUSES OF DEFLATION OF SALINE-FILLED IMPLANTS INCLUDE, BUT ARE NOT LIMITED TO THE FOLLOWING EVENTS: EXCESSIVE STRESSES OR MANIPULATIONS AS MAY OCCUR DURING NORMAL, DAILY ROUTINES INCLUDING CUSTOMARY. 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. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE. CONCOMITANT PRODUCTS: 500CC MENTOR SMOOTH ROUND HIGH PROFILE MEMORYGEL BREAST IMPLANT, CATALOG: 3505004BC, LOT: 5885092, SERIAL NUMBER: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED RUPTURE POST PROCEDURE. THE LEFT SIDED RUPTURE WAS CONFIRMED BY A MAMMOGRAM ON (B)(6) 2019. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87659 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3505004BC 5870223 00081317000532

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention