BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 7381770 · Received March 29, 2018

    Report

    Report Number
    1645337-2018-01838
    Event Type
    Malfunction
    Date Received
    March 29, 2018
    Date of Event
    February 21, 2018
    Report Date
    March 1, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001485
    PMA / PMN Number
    P990075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON 7/20/2018, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE COMPLAINT DEVICE. AS A RESULT, THE MANUFACTURING DATE AND EXPIRATION DATE FIELDS HAVE BEEN UPDATED. 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. 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. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 550CC SALINE CATALOG #3502550 LOT #6941305 SN #(B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-OPERATION OF A PATIENT WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 550CC SALINE BREAST PROSTHESES, SILVER FLECKS WERE FOUND DIRECTLY ON THE BREAST PROSTHESES. THE SURGERY WAS DELAYED FOR TWO HOURS AS A NEW IMPLANTS WERE ACQUIRED, BUT THE PROCEDURE WAS COMPLETED. THERE WAS NO ADDITIONAL PROCEDURE NEEDED AND NO PATIENT CONSEQUENCES WERE REPORTED. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224450 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6934854 00081317001485

    Patients

    Seq Age Sex Outcome Treatment
    1