BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAL SILTEX RND DIAP PKG 350CC

    MDR report key: 8312814 · Received February 6, 2019

    Report

    Report Number
    1645337-2019-08370
    Event Type
    Injury
    Date Received
    February 6, 2019
    Date of Event
    December 1, 2018
    Report Date
    January 11, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001805
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 2/8/2019 MENTOR BECAME AWARE OF THE PRESENCE OF BILATERAL CAPSULAR CONTRACTURE IN ADDITION TO THE LEFT DEFLATION REPORTED PREVIOUSLY. THIS REPORT RELATES TO THE LEFT PROSTHESIS. SEE 1645337-2019-08922 FOR CONTRALATERAL PROSTHESIS REPORT. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 232548, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE RETURNED PRODUCT WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON 3/8/2019. DEVICE EVALUATION SUMMARY: IT WAS REPORTED THAT A 54-YEAR-OLD CAUCASIAN FEMALE UNDERWENT BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 350CC SALINE PROSTHESIS AND EXPERIENCED DEFLATION POST PROCEDURE. LEFT SIDED DEFLATION WAS DIAGNOSED BY A PHYSICIAN POST PROCEDURE. UPON RECEIPT BY MENTOR THE DEVICE CONTAINED NO FLUID. YELLOW MATERIAL WAS OBSERVED WITHIN THE DEVICE AND ON THE SHELL SURFACE. DURING INITIAL EVALUATION A RENT WAS OBSERVED ON THE POSTERIOR ASPECT MEASURING APPROXIMATELY 0.5 CM. PARALLEL LINES OF SHELL WEAR WERE OBSERVED ON THE ANTERIOR ASPECT, SUGGESTING IN-VIVO FOLDING OR CREASING OF THE DEVICE. NO OTHER ANOMALIES WERE OBSERVED. MENTOR PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE IN ADDITION TO THOROUGH IN-PROCESS TESTING DURING SEVERAL STAGES OF THE MANUFACTURING PROCESS. THE MENTOR PRODUCT ANALYSIS LAB CONCLUDED THAT THE RENT 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. NONETHELESS, A MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT WAS PERFORMED AND IT DID NOT PROVIDE CONCLUSIVE EVIDENCE OF WHAT COULD BE THE ROOT CAUSE. AT THIS TIME IS NOT POSSIBLE TO DETERMINE THE ORIGIN OF THE YELLOW MATERIAL OBSERVED. BECAUSE MENTOR PRODUCT ANALYSIS LAB WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. 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 REPORTED COMPLAINT OF CAPSULAR CONTRACTURE IN THE PATIENT WAS THE RESULT OF THE BODY¿S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. CAPSULAR CONTRACTURE AND DEFLATION ARE KNOWN COMPLICATIONS ASSOCIATED WITH THESE DEVICES AND ARE REFERENCED IN OUR CURRENT 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. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: MENTOR SILTEX ROUND MODERATE PROFILE 350CC SALINE PROSTHESIS, CATALOG #3542655, LOT #232548. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE UNDERWENT BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 350CC SALINE PROSTHESIS AND EXPERIENCED DEFLATION POST PROCEDURE. LEFT SIDED DEFLATION WAS DIAGNOSED BY A PHYSICIAN POST PROCEDURE. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103772 SAL SILTEX RND DIAP PKG 350CC PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 232548 00081317001805

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention