BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINICAL GEL SMOOTH

    MDR report key: 7448927 · Received April 20, 2018

    Report

    Report Number
    1645337-2018-02273
    Event Type
    Injury
    Date Received
    April 20, 2018
    Date of Event
    February 1, 2018
    Report Date
    March 26, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON 07/27/18, IT WAS REPORTED TO MENTOR THAT THE DEVICE EVALUATION AND INVESTIGATION HAVE BEEN COMPLETED. UPON RECEIPT BY MENTOR, THE GEL CONTAINED IN THE DEVICE APPEARS CLEAR. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE. GEL WAS OBSERVED ON THE SHELL SURFACE. UPON VISUAL EXAMINATION, THE DEVICE WAS SEVERELY RENTED. NO OTHER ANOMALIES WERE DISCOVERED. 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. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. CAPSULAR CONTRACTURE IS THE RESULT OF THE BODY¿S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. THE SEVERITY LEVEL FOR THIS COMPLAINT CODE WAS DETERMINED TO BE A S3, WHICH IS DEFINED AS: NECESSITATES INTRUSIVE MEDICAL OR SURGICAL INTERVENTION. BECAUSE PE WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 06/25/18, IT WAS REPORTED TO MENTOR THAT 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. IN ADDITION, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH GEL MENTOR MEMORYGEL BREAST IMPLANT 275CC SERIAL NUMBER (B)(4), LOT 7542664 ON THE LEFT BREAST IMPLANT AND WITH GEL MENTOR MEMORYGEL BREAST IMPLANTS 275CC, SERIAL NUMBER (B)(4), LOT 7542664 ON THE RIGHT BREAST IMPLANT ON (B)(6) 2018. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, IT WAS REPORTED TO MENTOR THAT THE PATIENT SEX IN THE INITIAL REPORT WAS REPORTED INCORRECTLY. THE PATIENT SEX IS FEMALE. 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: CLINICAL GEL SMOOTH, CATALOG NUMBER 350-7300BCG, LOT NUMBER 220193 MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 04/21/18, IT WAS REPORTED TO MENTOR THAT THE DEVICE HISTORY RECORD ( DHR) OF LOT NUMBER 220193 REVIEWED 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A CLINICAL GEL SMOOTH BREAST IMPLANT AND EXPERIENCED BILATERAL RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THE CAPSULAR CONTRACTURE AND RUPTURE WERE DIAGNOSED BY MAMMOGRAM BY THE HEALTHCARE PROFESSIONAL ON (B)(6) 2018. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291408 CLINICAL GEL SMOOTH PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FTR MENTOR TEXAS 220193

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other