BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7287904 · Received February 21, 2018

    Report

    Report Number
    1645337-2018-01012
    Event Type
    Injury
    Date Received
    February 21, 2018
    Date of Event
    January 24, 2018
    Report Date
    January 24, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001263
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 07/12/2018, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2018. THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 5821628 COULD NOT BE REVIEWED AS THE QUALITY OPERATIONS TEAM WAS UNABLE TO LOCATE THE PHYSICAL DHR FILE. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE AND ADDRESS THIS ISSUE. ON 07/26/2018, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. UPON RECEIPT BY MENTOR, THE DEVICE CONTAINED NO FLUID. BROWN MATERIAL WAS OBSERVED WITHIN THE DEVICE. DURING EVALUATION A CREASE WAS OBSERVED ON THE POSTERIOR ASPECT. A RENT WAS DISCOVERED WITHIN THE CREASE, MEASURING APPROXIMATELY 0.1 CM. A SECOND RENT WAS OBSERVED ON THE ANTERIOR ASPECT, MEASURING APPROXIMATELY 0.7 CM. BECAUSE THE AUTHORIZATION FOR RETURN AND EXAMINATION OF MEDICAL DEVICE FORM WAS NOT SIGNED AND/OR RETURNED TO MENTOR, THE PRODUCT EVALUATION (PE) TEAM WAS PRECLUDED FROM FURTHER EVALUATING THE DEVICE. COMPLAINT WAS CONFIRMED. MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE, PE CONCLUDED THAT THE RENT AND CREASE OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. 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. 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; HOWEVER, DEFLATION TRENDS FOR MENTOR SALINE-FILLED DEVICES WILL CONTINUE TO BE MONITORED BY QUALITY ASSURANCE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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 DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: MENTOR SMOOTH ROUND MODERATE PROFILE 375CC SALINE BREAST PROSTHESIS, CAT. #3501660, SERIAL #(B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2018, THE MENTOR FAILURE ANALYSIS LAB 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. ON (B)(6) 2018, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE PATIENT¿S REPLACEMENT PROCEDURE. EXPLANTED DEVICES WERE REPLACED WITH MENTOR SMOOTH ROUND MODERATE PROFILE 375CC AND MENTOR SMOOTH ROUND MODERATE PROFILE 375CC SALINE BREAST PROSTHESES. AN EXPLANTATION DATE WAS NOT PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 350CC SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128967 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5821628 00081317001263

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other