BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 7494640 · Received May 8, 2018

    Report

    Report Number
    1645337-2018-02648
    Event Type
    Injury
    Date Received
    May 8, 2018
    Date of Event
    March 29, 2018
    Report Date
    April 12, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON 5/29/2018, MENTOR RECEIVED INFORMATION THAT IDENTIFIED THE INITIALLY REPORTED UNKNOWN DEVICE: DATE OF EVENT: (B)(6) 2018, BRAND NAME: MENTOR MEMORYGEL BREAST IMPLANT, PROCODE: FTR, COMMON DEVICE NAME: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED: CATALOG: 3505504BC, LOT: 5548155, UNIQUE IDENTIFIER (UDI): (B)(4), PMA/ 510(K): P030053. ON 6/8/2018, MENTOR WAS NOTIFIED THAT THE LEFT SIDE DEVICE MIGRATED OUT OF POCKET AND CAUSED BREAST PAIN. CONCOMITANT PRODUCTS: LEFT MENTOR MEMORYGEL BREAST IMPLANT 550C GEL PROSTHESIS, CATALOG: 3505504BC, LOT: 5626268. DEVICE EVALUATION COMPLETED ON 6/26/2018. SUMMARY: IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 550C GEL PROTHESIS ON THE RIGHT AND AN UNKNOWN MENTOR GEL PROSTHESIS ON THE LEFT. IN 2004, THE PATIENT EXPERIENCED RIGHT DEVICE RUPTURE AND LEFT SIDE DEVICE MIGRATION OUT OF POCKET AND BREAST PAIN. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 600CC GEL PROSTHESES ON (B)(6) 2018. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. THE DEVICE WAS RECEIVED AT MENTOR CONTAINING A GEL THAT APPEARED CLOUDY. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE. GEL WAS OBSERVED ON THE SHELL SURFACE. UPON INITIAL INSPECTION, THE DEVICE WAS SEVERELY RENTED. MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT GAVE NO INDICATIONS AS TO CAUSE. NO OTHER ANOMALIES WERE DISCOVERED. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE. THE DHR WAS REVIEWED ON 6/22/2018, 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. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. RUPTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 5/3/2018. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATION AND ANALYSIS HAVE BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH AN UNKNOWN MENTOR SALINE PROSTHESIS. RUPTURE ON THE RIGHT BREAST PROSTHESIS WAS DIAGNOSED POST PROCEDURE DURING EXCHANGE SURGERY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 600CC GEL PROSTHESES ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337263 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5548155

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention