BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 11949456 · Received June 7, 2021

    Report

    Report Number
    1645337-2021-06364
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    January 1, 2019
    Report Date
    May 11, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001317
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON JUNE 29, 2021, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. ON JULY 1, 2021, MENTOR BECAME AWARE OF THE FOLLOWING, AND ASSOCIATED FIELDS HAVE BEEN UPDATED: FIELD D4 FOR LOT NUMBER HAS BEEN UPDATED TO "241895". FIELD D4 FOR SERIAL NUMBER HAS BEEN UPDATED TO (B)(6). 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. ON JULY 8, 2021, DEVICE EVALUATION WAS COMPLETED. DEVICE EVALUATION SUMMARY: MENTOR CONDUCTED A VISUAL INSPECTION, LEAK TEST, AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. DURING THE VISUAL EVALUATION, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED ON THE SAL SMOOTH RND DIAP 575CC RETURNED DEVICE. LEAK TESTING WAS PERFORMED, IN ACCORDANCE WITH MENTOR PROCEDURES, AND A TEAR WAS OBSERVED ON THE ANTERIOR ASPECT MEASURING APPROXIMATELY 0.1 CM. MICROSCOPIC EXAMINATION WAS PERFORMED ON THE EDGES OF THE RUPTURE, AND PARALLEL STRIATIONS WERE FOUND IN THE WHOLE AREA OF THE TEAR. PARALLEL STRIATIONS ARE CONSISTENT WITH MARKINGS MADE BY A SHARP OBJECT PERFORATING THE IMPLANT SHELL. BASED ON THE INFORMATION CURRENTLY AVAILABLE, MICROSCOPIC EXAMINATION OF THE RETURNED PRODUCT INDICATES THAT THE IMPLANT COULD HAVE BEING DAMAGED DURING OR SUBSEQUENT TO IMPLANTATION. THE PRODUCT INSERT DATA SHEET CAUTIONS TO NOT ALLOW CAUTERY DEVICES OR SHARP INSTRUMENTS, SUCH AS SCALPELS, SUTURE NEEDLES, HYPODERMIC NEEDLES, HEMOSTATS, ADSON FORCEPS OR SCISSORS TO CONTACT THE DEVICE DURING THE IMPLANTATION OR OTHER SURGICAL PROCEDURES. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: LEFT DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) BLACK OR AFRICAN AMERICAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 575CC MENTOR SMOOTH ROUND MODERATE PROFILE AND EXPERIENCED BREAST IMPLANT DEFLATION, AND A POCKET THAT FELT LIKE A BUBBLE ON HER LEFT SIDE POSTOPERATIVELY. THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER 3503380 ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842653 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3501690 241895 00081317001317

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention