BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 12866405 · Received November 23, 2021

    Report

    Report Number
    1645337-2021-13064
    Event Type
    Injury
    Date Received
    November 23, 2021
    Date of Event
    November 1, 2021
    Report Date
    November 4, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001256
    PMA / PMN Number
    P990075
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 03-DEC-2021, 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT EXPERIENCED DEFLATION IN THE BREAST IMPLANT. THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION, MICROSCOPIC EXAMINATION, AND THICKNESS MEASUREMENT OF THE RETURNED DEVICE. DURING THE VISUAL ANALYSIS OF THE RETURNED SAMPLE, A TEAR AT A JUNCTION AT THE VALVE SYSTEM WAS OBSERVED. A MICROSCOPIC EXAMINATION WAS PERFORMED, AND THE CAUSE OF THE TEAR COULD NOT BE IDENTIFIED. THEREFORE, A THICKNESS MEASUREMENT WAS CONDUCTED ON THE SHELL AT THE TEAR, AND THE THICKNESS WAS WITHIN MANUFACTURING SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ALTHOUGH NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: ACCORDING TO THE PRODUCT INSERT DATA SHEET, THE VALVE SYSTEM CAN BE DAMAGED BY IMPROPER USE OF THE FILL-TUBE STYLET. CARE SHOULD BE TAKEN THAT THE STYLET ENTERS THE VALVE SMOOTHLY. USE THE THUMB AND FOREFINGER TO STABILIZE/SUPPORT THE VALVE SEAT AND GENTLY PUSH THE STYLET TIP INTO THE VALVE OPENING. OVERSTRESSING THE VALVE MATERIAL MAY RESULT IN PUNCTURES OR TEARS AND SUBSEQUENT DEFLATION MAY OCCUR. USE ONLY THE FILL TUBE STYLE PROVIDED WITH THIS PRODUCT. TAKE CARE NOT TO PUNCTURE THE DIAPHRAGM VALVE OR THE SHELL WITH THE STYLET TIP. CARE MUST ALSO BE TAKEN WHEN THE FILL TUBE STYLE IS REMOVED TO PREVENT DAMAGE TO THE VALVE ASSEMBLY. A SECOND PRODUCT WAS RECEIVED (LOT #6864249). NO ADVERSE EVENTS WERE REPORTED FOR THIS CONCOMITANT (CONTRALATERAL) DEVICE. THEREFORE, NO FURTHER ANALYSIS IS REQUIRED. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    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 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: BREAST PROSTHESIS DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 325CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH AN UNSPECIFIED MENTOR BREAST PROSTHESIS ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1763152 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3501650 7741741 00081317001256

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention