BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8108280 · Received November 27, 2018

    Report

    Report Number
    1645337-2018-07065
    Event Type
    Injury
    Date Received
    November 27, 2018
    Date of Event
    August 27, 2018
    Report Date
    November 7, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 01/04/2019, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE SUSPECT MEDICAL DEVICE. IT IS A MENTOR MEMORYGEL BREAST IMPLANT 425CC GEL BREAST PROSTHESIS, CATALOG #3504254BC, LOT #271774, SERIAL # UNKNOWN, PMA #P030053, UDI # (B)(4). ON 01/04/2019, THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 271774 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. ON 01/04/2019, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. UPON RECEIPT BY MENTOR, THE DEVICE CONTAINED GEL WITH CLEAR APPEARANCE. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE. GEL WAS OBSERVED ON THE SHELL SURFACE. DURING VISUAL EXAMINATION, MENTOR PRODUCT ANALYSIS LAB OBSERVED THE DEVICE WAS SEVERELY RENTED. BECAUSE THE AUTHORIZATION FOR RETURN AND EXAMINATION OF MEDICAL DEVICE FORM WAS NOT SIGNED AND/OR RETURNED TO MENTOR, MENTOR PRODUCT ANALYSIS LAB WAS PRECLUDED FROM FURTHER EVALUATING THE DEVICE. NO OTHER ANOMALIES WERE FOUND. MENTOR PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE IN ADDITION TO THOROUGH IN-PROCESS TESTING DURING SEVERAL STAGES OF THE MANUFACTURING PROCESS. MENTOR PRODUCT ANALYSIS LAB CONCLUDED THAT THE RENT OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE COMPLAINT OF RUPTURE WAS CONFIRMED SINCE THE DEVICE WAS FOUND SEVERELY RENTED. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE. 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; HOWEVER, COMPLAINT TRENDS FOR MENTOR DEVICES WILL CONTINUE TO BE MONITORED BY QUALITY ASSURANCE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE MENTOR PRODUCT 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. 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 A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 425CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND AN UNSPECIFIED MENTOR GEL BREAST PROSTHESIS (RIGHT DEVICE) WHEN BOTH PROSTHESES RUPTURED AFTER IMPLANTATION. BILATERAL RUPTURE WAS CONFIRMED BY A DOCTOR¿S EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 475CC GEL BREAST PROSTHESES ON (B)(6) 2018. THIS MEDWATCH REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948195 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 271774

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention