BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 7686287 · Received July 13, 2018

    Report

    Report Number
    1645337-2018-04219
    Event Type
    Injury
    Date Received
    July 13, 2018
    Date of Event
    June 14, 2018
    Report Date
    June 18, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000716
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 8/7/2018, 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. ADDITIONAL INFORMATION INDICATED THAT THE LOT NUMBER IS 2223818. IN THIS REPORT DATE OF EVENT IS (B)(6) 2018, WHICH MAKES THE PATIENT AGE TO BE (B)(6) YEARS OLD AT THE TIME OF THE EVENT. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REPLACEMENT DEVICES ARE AS FOLLOW: LEFT REPLACED WITH CATALOG NUMBER 3504251BC, LOT NUMBER 7586388, SERIAL NUMBER (B)(4), AND RIGHT REPLACED WITH CATALOG NUMBER 3504251BC LOT NUMBER 7562737, SERIAL NUMBER (B)(4). THIS REPORT IS FOR THE RIGHT IMPLANT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE DEVICE CONTAINED CLOUDY GEL. BROWN MATERIAL WAS OBSERVED WITHIN THE DEVICE AND GEL, WHITE AND BROWN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. DURING INITIAL EXAMINATION A RENT WAS OBSERVED ON THE POSTERIOR ASPECT, MEASURING APPROXIMATELY 2.8 CM. MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT AND MISSING MATERIAL GAVE NO INDICATIONS AS TO CAUSE. NO OTHER ANOMALIES WERE OBSERVED. COMPLAINT WAS CONFIRMED. MENTOR PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE IN ADDITION TO THOROUGH IN-PROCESS TESTING DURING SEVERAL STAGES OF THE MANUFACTURING PROCESS. PRODUCT EVALUATION TEAM CONCLUDED THAT RENTS ARE SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND ON THE DEVICE. NONETHELESS, A MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT WAS PERFORMED AND IT DID NOT PROVIDE CONCLUSIVE EVIDENCE OF WHAT COULD BE THE ROOT CAUSE. AT THIS TIME IS NOT POSSIBLE TO DETERMINE THE ORIGIN OF THE WHITE AND BROWN MATERIAL OBSERVED. ALL THE IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES AND DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. ON 9/10/2018, 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON PREVIOUS REPORT THERE WAS A TYPO ERROR ON THE LOT NUMBER OF THE RIGHT IMPLANT AND WAS REPORTED AS 2223818, AND THE CORRECT LOT IS 222381S.(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. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. CONCOMITANT PRODUCTS: LEFT-MENTOR MEMORYGEL SILTEX MOD-RND 375 CC BREAST IMPLANT, SERIAL (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 SILTEX MOD-RND 375 CC FOR THE LEFT SIDE AND 400 CC FOR THE RIGHT SIDE BREAST IMPLANTS THAT BILATERALLY RUPTURED AFTER IMPLANTATION. THE ISSUE WAS REVEALED BY MRI. AS A RESULT PATIENT SCHEDULED FOR BILATERAL REPLACEMENT WITH MENTOR GEL IMPLANT ON (B)(6) 2018. THIS REPORT IS FOR THE RIGHT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528912 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 222381S 00081317000716

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention