BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 7686524 · Received July 13, 2018

    Report

    Report Number
    1645337-2018-04248
    Event Type
    Injury
    Date Received
    July 13, 2018
    Date of Event
    May 25, 2018
    Report Date
    June 27, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000068
    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

    DURING THE PRODUCT INVESTIGATION PROCESS, IT WAS DISCOVERED THAT WRONG PRODUCT RECEIVED. AS A RESULT, NO FURTHER ANALYSIS WILL TAKE PLACE AT THIS TIME. IF WRONG PRODUCT CLARIFICATION IS RECEIVED AT A LATER DATE, THE PRODUCT EVALUATION WILL BE PERFORMED AND REPORTED ACCORDINGLY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE MENTOR FAILURE ANALYSIS LAB HAS 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 THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. CONCOMITANT MEDICAL PRODUCTS: RIGHT-MENTOR MEMORYGEL GEL MOD-RND 225CC, SERIAL NUMBER (B)(4), LOT NUMBER 1002702, CATALOG NUMBER 3507225BC. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL GEL MOD-RND 225CC THAT BILATERALLY RUPTURED AFTER IMPLANTATION. THE ISSUE WAS REPORTED BY THE DOCTOR, AS A RESULT PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT AS FOLLOW: LEFT REPLACED WITH CATALOG NUMBER SCM-140, SERIAL NUMBER (B)(4), AND RIGHT REPLACED WITH CATALOG NUMBER SCM-195 SERIAL NUMBER (B)(4) ON (B)(6) 2018. THIS REPORT IS FOR THE LEFT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530022 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 1002702 00081317000068

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention