BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 7325541 · Received March 8, 2018

    Report

    Report Number
    1645337-2018-01368
    Event Type
    Injury
    Date Received
    March 8, 2018
    Date of Event
    January 26, 2018
    Report Date
    February 12, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX ROUND MODERATE PROFILE 425CC SALINE PROSTHESES. DEFLATION WAS SUSPECTED BY THE PATIENT, AFTER ONE BREAST APPEARED LOWER THAN THE OTHER. THERE IS NO INFORMATION REGARDING AN OFFICIAL DIAGNOSIS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 475CC GEL PROSTHESES ON (B)(6) 2018. THE DEVICE WAS RECEIVED AT MENTOR WITHOUT FLUID. BROWN MATERIAL WAS OBSERVED WITHIN THE DEVICE. YELLOW MATERIAL WAS OBSERVED ON THE SHELL SURFACE. THE PRODUCT EVALUATION TEAM DISCOVERED A RENT MEASURING APPROXIMATELY 0.4 CM WITHIN AN AREA OF SILTEX CRACKING ON THE POSTERIOR ASPECT. NO OTHER ANOMALIES WERE DISCOVERED. POTENTIAL CAUSE: 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 OR THE ETIOLOGY OF THE BROWN AND YELLOW MATERIAL FOUND ON THE DEVICE. THE DHR WAS REVIEWED ON 6/20/2018, 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. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    MENTOR RECEIVED THE FOLLOWING INFORMATION ON (B)(6) 2018. THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 475CC GEL PROSTHESES ON (B)(6) 2018. (B)(4).

    Additional Manufacturer Narrative · 1

    ON 5/16/2018, MENTOR RECEIVED INFORMATION THAT IDENTIFIED THE INITIALLY REPORTED UNKNOWN. DEVICE: BRAND NAME: MENTOR SILTEX ROUND MODERATE PROFILE. COMMON DEVICE NAME: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE; PROCODE: FWM, CATALOG: 3542670, LOT: 5997522, UNIQUE IDENTIFIER( UDI): (B)(4), PMA/ 510(K): P990075. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH AN UNKNOWN MENTOR SALINE PROSTHESIS. DEFLATION WAS SUSPECTED BY THE PATIENT, AFTER ONE BREAST APPEARED LOWER THAN THE OTHER. THERE IS NO INFORMATION REGARDING AN OFFICIAL DIAGNOSIS. AS A RESULT, AN EXPLANT WAS PERFORMED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167798 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5997522

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention