BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7587971 · Received June 11, 2018

    Report

    Report Number
    1645337-2018-03590
    Event Type
    Injury
    Date Received
    June 11, 2018
    Date of Event
    May 18, 2018
    Report Date
    May 21, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001270
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 6/27/2018, THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. MENTOR ALSO BECAME AWARE THAT THE REPLACEMENT DEVICES WERE THE FOLLOWING: (LEFT) MENTOR SMOOTH ROUND MODERATE PROFILE 350CC SALINE CATALOG: 3501655, LOT: 7508732, SN: (B)(4) AND (RIGHT) MENTOR SMOOTH ROUND MODERATE PROFILE 350CC SALINE CATALOG: 3501655, LOT: 7385379, SN: (B)(4). DEVICE INVESTIGATION SUMMARY: UPON RECEIPT BY MENTOR, THE DEVICE CONTAINED NO FLUID. YELLOW MATERIAL WAS OBSERVED WITHIN THE DEVICE. NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. EVALUATION OF THE DEVICE REVEALED A RENT MEASURING APPROXIMATELY 0.4 CM WITHIN A CREASE ON THE POSTERIOR ASPECT. NO OTHER ANOMALIES WERE DISCOVERED. THE COMPLAINT OF DEFLATION WAS CONFIRMED. MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE, PRODUCT EVALUATION CONCLUDED THAT THE RENT AND CREASE OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. 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. 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. 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 PRODUCTS: MENTOR SMOOTH ROUND MODERATE PROFILE 375CC SALINE CATALOG: 3501660 LOT: 5915094 SN: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) -YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND MODERATE PROFILE 375CC SALINE BREAST PROSTHESES. DEFLATION OF THE LEFT BREAST PROSTHESIS WAS DETERMINED. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430441 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5915094 00081317001270

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention