BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 10574125 · Received September 23, 2020

    Report

    Report Number
    1645337-2020-12013
    Event Type
    Injury
    Date Received
    September 23, 2020
    Date of Event
    July 8, 2019
    Report Date
    September 11, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317001102
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, DEVICE EVALUATION WAS COMPLETED. DEVICE EVALUATION SUMMARY: MENTOR CONDUCTED A VISUAL INSPECTION. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE SMOOTH HPG, 800CC BREAST IMPLANT. A SECOND PRODUCT WAS RECEIVED (PRODUCT CODE 3544450 AND LOT NUMBER 5894190). NO ADVERSE EVENTS WERE REPORTED FOR THIS CONCOMITANT (CONTRALATERAL) DEVICE, THEREFORE NO FURTHER ANALYSIS IS REQUIRED. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, MENTOR BECAME AWARE OF THE FOLLOWING: LEFT SIDE RUPTURE WAS SUSPECTED. HOWEVER, THE LEFT IMPLANT WAS FOUND INTACT DURING BILATERAL EXPLANTATION AND REPLACEMENT SURGERY WITH CATALOG SHPX755; SERIAL NUMBER (B)(6), ON THE RIGHT SIDE, AND WITH CATALOG SHPX755; SERIAL NUMBER (B)(6), ON THE LEFT SIDE ON (B)(6) 2020. FIELD D6B HAS BEEN UPDATED ON THIS FORM TO (B)(6) 2020. FIELD H6 MEDICAL DEVICE PROBLEM CODE HAS BEEN UPDATED TO "ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM" ON THIS FORM. ON (B)(6) 2021, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 (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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: LEFT RUPTURE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WITH UNKNOWN ETHNICITY AND RACE UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 450CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED LEFT SIDE BREAST IMPLANT RUPTURE POSTOPERATIVELY. MRI TAKEN ON (B)(6) 2019 REPORTED THIN LINEAR FLUID, AND LEFT IMPLANT APPEARED DIFFERENT THAN THE RIGHT. THE PATIENT UNDERWENT BILATERAL EXPLANTATION, AND REPLACEMENT ON (B)(6) 2020. FOLLOW-UP ARE IN PROGRESS. SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041134 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3544450 5892729 00081317001102

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention