BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8682340 · Received June 10, 2019

    Report

    Report Number
    1645337-2019-13504
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    April 16, 2019
    Report Date
    May 12, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000853
    PMA / PMN Number
    P030053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: DURING EVALUATION OF THE SAMPLE A TEAR WAS OBSERVED ON THE ANTERIOR VIEW MEASURING APPROXIMATELY 3.5 CM. NO OTHER ANOMALIES WERE DISCOVERED. SINCE 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 FURTHER INVESTIGATION WILL BE CONDUCTED ON THIS COMPLAINT AS THERE ARE NO INDICATION THAT THE ISSUE FOUND IS RELATED TO THE MANUFACTURING PROCESS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 06/10/2019, 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. PATIENT CODE WAS UPDATED FROM NO PATIENT CONSEQUENCE TO NO ADVERSE EVENT PER CORRECT CODIFICATION. 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: DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERGOING A PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL 275CC SILICONE BREAST IMPLANTS WHICH THE LEFT SIDE DEFLATED INTRAOPERATIVELY. AS A RESULT THE IMPLANT WAS REPLACED WITH THE NEW ONE WITH CATALOG NUMBER 3542751, LOT NUMBER 7662934) ON (B)(6) 2019. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476748 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 7661658 00081317000853

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR