BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7390392 · Received April 2, 2018

    Report

    Report Number
    1645337-2018-01846
    Event Type
    Injury
    Date Received
    April 2, 2018
    Date of Event
    February 20, 2018
    Report Date
    March 5, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON 06/26/2018, MENTOR BECAME AWARE THAT THE SUSPECT MEDICAL DEVICE IS A MENTOR SMOOTH ROUND MODERATE PROFILE 425CC SALINE BREAST PROSTHESIS, CATALOG #3501670, LOT #5677822, PMA #P990075, UDI # (B)(4). ON 07/09/2018, 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 · 0

    ON 07/15/2018, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. THE PRODUCT EVALUATION (PE) TEAM DISCOVERED A RENT MEASURING APPROXIMATELY < 0.1 CM WITHIN AN AREA OF SHELL ABRASION ON THE ANTERIOR ASPECT. IN ADDITION, CREASES WERE NOTICED ON BOTH VIEWS OF THE IMPLANT. NO OTHER ANOMALIES WERE DISCOVERED. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE. 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; HOWEVER, DEFLATION TRENDS FOR MENTOR SALINE-FILLED DEVICES WILL CONTINUE TO BE MONITORED BY QUALITY ASSURANCE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEEN DISCARDED. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH AN UNSPECIFIED MENTOR SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. DEFLATION WAS DIAGNOSED BY A MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED BREAST PROSTHESES ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232235 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5677822

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention