BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 8421081 · Received March 14, 2019

    Report

    Report Number
    1645337-2019-09321
    Event Type
    Injury
    Date Received
    March 14, 2019
    Date of Event
    February 21, 2019
    Report Date
    February 22, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001386
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 3/19/19, IT WAS REPORTED TO MENTOR THAT THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. ON 4/3/19, IT WAS REPORTED TO MENTOR THAT THE DEVICE EVALUATION AND INVESTIGATION HAVE BEEN COMPLETED. UPON RECEIPT BY MENTOR, THE DEVICE CONTAINED NO FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. DURING THE INITIAL EVALUATION A SEPARATED MATERIAL, MEASURING APPROXIMATELY 4.9 CM X 4.8 CM WAS DISCOVERED ON THE ANTERIOR AND POSTERIOR ASPECT. MICROSCOPIC EXAMINATION WAS PERFORMED. NO EVIDENCE OF INSTRUMENT DAMAGE WAS OBSERVED. NO OTHER ANOMALIES WERE OBSERVED. DEFLATION COMPLAINT WAS CONFIRMED. MENTOR PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE IN ADDITION TO THOROUGH IN-PROCESS TESTING DURING SEVERAL STAGES OF THE MANUFACTURING PROCESS. MENTOR PRODUCT ANALYSIS LAB CONCLUDED THAT RENTS ARE 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. THE SEVERITY LEVEL FOR THIS COMPLAINT CODE WAS DETERMINED TO BE A S3, WHICH IS DEFINED AS: NECESSITATES INTRUSIVE MEDICAL OR SURGICAL INTERVENTION. BECAUSE MENTOR PRODUCT ANALYSIS LAB 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 · 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. THE MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. CONCOMITANT PRODUCTS: SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 275CC, CATALOG NUMBER: 3502275, SERIAL NUMBER: (B)(4), LOT NUMBER: 6973233. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 275CC AND EXPERIENCED DEFLATION ON THE RIGHT BREAST IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215180 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 7479539 00081317001386

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention