BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 9140582 · Received October 1, 2019

    Report

    Report Number
    1645337-2019-20538
    Event Type
    Injury
    Date Received
    October 1, 2019
    Date of Event
    September 30, 2018
    Report Date
    September 17, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON SEPTEMBER 8, 2020, MENTOR BECAME AWARE THAT THE DATE OF SURGERY WAS (B)(6) 2020. HENCE, FOLLOWING FIELDS HAVE BEEN UPDATED ON THIS FORM: IS REQUIRED INTERVENTION HAS BEEN SELECTED UNDER SECTION B; FIELD B2. FIELD D7 EXPLANTATION DATE HAS BEEN UPDATED TO (B)(6) 2020. FIELD H6 PATIENT CODE "NO CODE AVAILABLE" HAS BEEN ADDED. FIELD H6 METHOD CODE HAS BEEN UPDATED TO "DEVICE NOT RETURNED." ON SEPTEMBER 11, 2020, MENTOR BECAME AWARE THAT PATIENT ALSO EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN. HENCE, PATIENT CODE CAPSULAR CONTRACTURE HAS BEEN ADDED TO FIELD H6 ON THIS FORM. THIS SUPPLEMENTAL REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, 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. THIS SUPPLEMENTAL REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    AS PER DEVICE RECEIVED ON OCTOBER 5, 2020, AND REPORTED UNDER PREVIOUS SUBMISSION, SECTION D HAS BEEN UPDATED WITH IMPACTED DEVICE INFORMATION ON THIS FORM AS FOLLOWS: - FIELD D1 FOR BRAND NAME HAS BEEN UPDATED TO "MENTOR SMOOTH ROUND MODERATE PROFILE" - FIELD D4 FOR CATALOG NUMBER HAS BEEN UPDATED TO "3501650" - FIELD D4 FOR LOT NUMBER HAS BEEN UPDATED TO "5861328" - FIELD D4 FOR UNIQUE IDENTIFIER( UDI) HAS BEEN UPDATED TO "(B)(4). - FIELD G5 FOR PMA/ 510(K) HAS BEEN UPDATED TO "P990075" A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. ON OCTOBER 9, 2020, MENTOR BECAME AWARE THAT PATIENT EXPERIENCED BAKER GRADE IV OF THE BILATERAL CAPSULAR CONTRACTURE REPORTED. ON OCTOBER 15, 2020, DEVICE EVALUATION WAS COMPLETED. DEVICE EVALUATION SUMMARY: DURING THE VISUAL EVALUATION, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED ON THE RETURNED DEVICE. AT THE PRESENT TIME, THERE IS NO SUFFICIENT EVIDENCE TO SHOW AN ASSOCIATION BETWEEN BREAST IMPLANTS AND GENERALIZED ILLNESS (ASSESSING THE RISKS OF BREAST IMPLANTS AND FDA¿S VISION FOR THE NATIONAL BREAST IMPLANT REGISTRY). MENTOR CONCLUDED THAT THE CAPSULAR CONTRACTURE IN THE PATIENT´S BREAST WAS THE RESULT OF THE BODY´S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. CAPSULAR CONTRACTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. THE AMERICAN SOCIETY OF PLASTIC SURGEONS RECOMMENDS AND ENCOURAGES MEMBER SURGEONS TO ALWAYS SUBMIT BREAST IMPLANTS, CAPSULE, AND EFFUSION TO PATHOLOGY FOR EXAMINATION. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THIS SUPPLEMENTAL REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE. 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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: AS OF NOW THERE IS NO INFORMATION REGARDING THE EXPLANT OR REOPERATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MEDWATCH NUMBER: MW5089183 THAT A FEMALE PATIENT WITH UNKNOWN AGE AND RACE UNDERWENT UNSPECIFIED BREAST SURGERY WITH A UNKNOWN SIZE UNKNOWN SALINE IMPLANT ON BOTH SIDES AND WAS PRESENTED WITH GENERALIZED ILLNESS INCLUDING FEELING VERY SICK, VISION CHANGES, ANXIETY, DEPRESSION, WHOLE BODY FEELS LIKE IT'S BURNING INSIDE, WEAK BODY, TIRED, AND LEFT LEG BELOW KNEE IS COMPLETELY NUMB AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934948 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5861328

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R