BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 7642448 · Received June 27, 2018

    Report

    Report Number
    1645337-2018-03899
    Event Type
    Injury
    Date Received
    June 27, 2018
    Date of Event
    May 9, 2016
    Report Date
    May 31, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001775
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 6/28/2018, ADDITIONAL INFORMATION INDICATED THAT THE DATE OF IMPLANTATION WAS ON (B)(6) 2002, AND IT WAS CONFIRMED THAT THE LOT NUMBER FOR THE LEFT IMPLANT IS 233596. THE PATIENT DID NOT EXPERIENCE ANY ACCOMPANYING SYMPTOMS, WAS NOT HOSPITALIZED, AND HAS SINCE FULLY RECOVERED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 8/25/2018, 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION 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. DURING VISUAL EXAMINATION OF THE DEVICE, PRODUCT EVALUATION TEAM OBSERVED A RENT ON THE POSTERIOR VIEW MEASURING APPROXIMATELY 0.5 CM. PARALLEL LINES OF SHELL WEAR WERE ALSO OBSERVED ON THE ANTERIOR ASPECT, SUGGESTING IN-VIVO FOLDING OR CREASING OF THE DEVICE. MICROSCOPIC EXAMINATION OF THE RENT EDGES GAVE NO INDICATION AS TO ITS CAUSE. NO OTHER ANOMALIES WERE FOUND. MENTOR PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE IN ADDITION TO THOROUGH IN-PROCESS TESTING DURING SEVERAL STAGES OF THE MANUFACTURING PROCESS. PE CONCLUDED THAT THE RENT OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE COMPLAINT OF DEFLATION WAS CONFIRMED SINCE A RENT WAS FOUND ON THE DEVICE. NONETHELESS, A MICROSCOPIC EXAMINATION OF THE RENT EDGES WAS PERFORMED, AND IT DID NOT PROVIDE CONCLUSIVE EVIDENCE OF WHAT COULD BE THE ROOT CAUSE. FURTHERMORE, AT THIS POINT IT IS ALSO NOT POSSIBLE TO DETERMINE THE ORIGIN OF THE YELLOW MATERIAL OBSERVED. . 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 THE RENT 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

    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. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR BOTH LOTS: (233596,194612) 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: LOT NUMBER: 233596 - EXPIRATION DATE: 10/31/2005, MANUFACTURING DATE: 10/01/2001, CATALOG NUMBER 3542640. LOT NUMBER: 194612- EXPIRATION DATE: 06/30/2003, MANUFACTURING DATE: 06/01/1999, CATALOG NUMBER 3542640, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN UNKNOWN BREAST AUGMENTATION WITH MENTOR SILTEX ROUND MODERATE PROFILE 275CC SALINE BREAST IMPLANTS WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. MENTOR DOES NOT KNOW THE LOT/SERIAL OF THE COMPLAINT DEVICE, ITS EITHER 233596 OR 194612. THE COMPLAINT FILE WILL BE REASSESSED IF ADDITIONAL INFORMATION COMES IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484058 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 233596 00081317001775

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| R