BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 8322702 · Received February 8, 2019

    Report

    Report Number
    1645337-2019-08410
    Event Type
    Injury
    Date Received
    February 8, 2019
    Date of Event
    January 14, 2019
    Report Date
    January 14, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001287
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT BY MENTOR, THE DEVICE CONTAINED NO FLUID. WHITE MATERIAL WAS OBSERVED WITHIN THE DEVICE AND NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. DURING EVALUATION A RENT WAS OBSERVED ON THE POSTERIOR ASPECT, MEASURING APPROXIMATELY 0.1 CM. MICROSCOPIC EXAMINATION WAS PERFORMED. NO EVIDENCE OF INSTRUMENT DAMAGE WAS OBSERVED. NO OTHER ANOMALIES WERE OBSERVED. THIS RECORD IS RELATED TO A CONCOMITANT DEVICE; NO ANOMALIES WERE OBSERVED ON IT. THEREFORE NO FURTHER INVESTIGATION IS REQUIRED. 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 THE RENT AND CREASE OCCURRED 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. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 6823218, AND NO NON-CONFORMANCE'S RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. AT THIS TIME IS NOT POSSIBLE TO DETERMINE THE ORIGIN OF THE WHITE MATERIAL. 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 · 0

    ON (B)(6) 2019, THE PRODUCT INVESTIGATION SUMMARY WAS UPDATED. THE SENTENCE, "THIS RECORD IS RELATED TO A CONCOMITANT DEVICE; NO ANOMALIES WERE OBSERVED ON IT," WAS UPDATED TO, "SECOND DEVICE WAS RECEIVED AND IS RELATED TO A CONCOMITANT DEVICE; NO ANOMALIES WERE OBSERVED ON IT." 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. THE MANUFACTURING RECORD EVALUATION (MRE) WAS REVIEWED, 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. CONCOMITANT MEDICAL PRODUCTS: 425CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE CATALOG: 3501670 LOT: 6823218 SN: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 425CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES, EXPERIENCED LEFT SIDE DEFLATION POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116087 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6823218 00081317001287

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention SEE H10