BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7409790 · Received April 9, 2018

    Report

    Report Number
    1645337-2018-02111
    Event Type
    Injury
    Date Received
    April 9, 2018
    Date of Event
    March 10, 2018
    Report Date
    March 12, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001287
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: FINDINGS: UPON RECEIPT BY MENTOR, THE DEVICE CONTAINED NO FLUID. DURING EVALUATION A CREASE WAS OBSERVED ON THE POSTERIOR ASPECT. LEAK TESTING OF THE DEVICE, IN ACCORDANCE WITH MENTOR PROCEDURES, REVEALED A RENT WITHIN THE CREASE MEASURING APPROXIMATELY 0.1 CM. COMPLAINT WAS CONFIRMED. MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE, PRODUCT EVALUATION TEAM CONCLUDED THAT THE RENT AND CREASE OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. DETERMINE THE ROOT CAUSE OF SUCH DAMAGE. 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. THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 243054 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. 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 PRODUCTS: RIGHT BREAST IMPLANT SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 425CC, LOT NUMBER 243384, CATALOG NUMBER 3501670. (B)(4).

    Additional Manufacturer Narrative · 1

    ON 5/16/2018, 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 PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT OF LEFT IMPLANT WITH CATALOG NUMBER 3502450, SERIAL NUMBER (B)(4) ON (B)(6) 2018. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND MODERATE PROFILE 425CC SALINE BREAST IMPLANTS WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. THE PATIENT NOTICED THE DEFLATION VISIBLY. 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
    252702 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 243054 00081317001287

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other