BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 12485815 · Received September 16, 2021

    Report

    Report Number
    1645337-2021-10388
    Event Type
    Injury
    Date Received
    September 16, 2021
    Report Date
    August 27, 2021
    Product Code
    FWM
    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 (B)(6) 2021, THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. PATIENT¿S IMPACTED PRODUCT IS A 250CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT, PRODUCT¿S LOT NUMBER IS 5926390. THE INVESTIGATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON (B)(6) 2021. DEVICE EVALUATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION, LEAK TESTING, AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE SM MPPS DV 250CC BREAST IMPLANT. LEAK TESTING WAS PERFORMED, IN ACCORDANCE WITH MENTOR PROCEDURES, AND A TEAR WAS NOTED ON THE ANTERIOR VIEW, 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 BEEN 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. 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. 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: DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST SURGERY WITH AN UNSPECIFIED SALINE BREAST IMPLANT EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382900 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM 5926390

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention