BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7803262 · Received August 21, 2018

    Report

    Report Number
    1645337-2018-05094
    Event Type
    Injury
    Date Received
    August 21, 2018
    Date of Event
    July 17, 2018
    Report Date
    July 24, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001249
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT BY MENTOR, THE DEVICE CONTAINED NO FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. DURING VISUAL EXAMINATION OF THE DEVICE, PRODUCT EVALUATION TEAMOBSERVED TWO RENTS; RENT A MEASURING APPROXIMATELY 0.4 CM DISCOVERED ON THE POSTERIOR VIEW AND RENT B MEASURING 2.1 CM DISCOVERED ON THE ANTERIOR VIEW. MICROSCOPIC EXAMINATION OF THE RENTS EDGES GAVE NO INDICATION AS TO THEIR CAUSE. NO OTHER ANOMALIES WERE FOUND. MENTOR PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE IN ADDITION TO THOROUGH IN-PROCESS TESTING DURING SEVERAL STAGES OF THE MANUFACTURING PROCESS. PRODUCT EVALUATION TEAM CONCLUDED THAT THE RENTS OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE COMPLAINT OF DEFLATION WAS CONFIRMED SINCE TWO RENTS WERE FOUND ON THE DEVICE. NONETHELESS, A MICROSCOPIC EXAMINATION OF THE RENTS EDGES WAS PERFORMED, AND IT DID NOT PROVIDE CONCLUSIVE EVIDENCE OF WHAT COULD BE THE ROOT CAUSE. MENTOR PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE IN ADDITION TO THOROUGH IN-PROCESS TESTING DURING SEVERAL STAGES OF THE MANUFACTURING PROCESS. PRODUCT EVALUATION TEAM CONCLUDED THAT THE RENTS OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. ALL THE IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING 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. (B)(4).

    Additional Manufacturer Narrative · 0

    ON 9/10/2018, 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. THIS REPORT INDICATES THE SERIAL NUMBER FOR THE LEFT IMPLANT IS (B)(4). CONCOMITANT PRODUCT: SERIAL NUMBER (B)(4). SERIAL NUMBER FOR THE REPLACEMENT PRODUCT IS (B)(4). THIS REPORT IS FOR THE LEFT IMPLANT. 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 DEVICE HISTORY RECORD (DHR) WAS 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. CONCOMITANT PRODUCTS: RIGHT MENTOR SMOOTH ROUND MODERATE PROFILE 300CC SALINE BREAST IMPLANT, CATALOG # 3501645, LOT NUMBER 5991387. INITIAL REPORTER PHONE: (B)(6). (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 MENTOR SMOOTH ROUND MODERATE PROFILE 300CC SALINE BREAST IMPLANTS WHICH BILATERALLY DEFLATED AFTER IMPLANTATION. THE ISSUE WAS DIAGNOSED BY ULTRASOUND. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT AS FOLLOW; LEFT REPLACED WITH CATALOG NUMBER 3501625, LOT NUMBER 7521520, AND RIGHT REPLACED WITH CATALOG NUMBER 3501645 ON (B)(6) 2018. THIS REPORT IS FOR THE LEFT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642003 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5985967 00081317001249

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention