BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 8270940 · Received January 23, 2019

    Report

    Report Number
    1645337-2019-08084
    Event Type
    Injury
    Date Received
    January 23, 2019
    Date of Event
    December 1, 2009
    Report Date
    January 3, 2019
    Manufacturer
    MENTOR TEXAS
    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 07-APR-2020, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. THE PATIENT REPORTED THAT HER LEFT BREAST PROSTHESIS CAVES IN, AND HER ARM IS SWOLLEN. HER LEFT BREAST IS IN PAIN AND IT FEELS HARD AND HEAVY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH NON-MENTOR BREAST PROSTHESES ON AN UNSPECIFIED DATE. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE. H6 PATIENT CODE 3191: MEDICAL DEVICE REMOVAL.. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 10/17/2019, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. - THE SUSPECT MEDICAL DEVICE IS A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 325CC SALINE BREAST PROSTHESIS, CATALOG #3502325, LOT NUMBER 5767525, SERIAL NUMBER (B)(4), UDI # (B)(4), PMA #P990075. 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. - THE CONCOMITANT PRODUCT IS A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 325CC SALINE BREAST PROSTHESIS, CATALOG #3502325, LOT #5767525, SERIAL # (B)(4). ON (B)(6) 2019, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: - THE PATIENT INITIALLY REPORTED THAT THE IMPLANTATION DATE WAS IN 2005. NEW INFORMATION STATES THAT THE IMPLANTATION DATE WAS IN (B)(6) 2009. - THE DATE OF EVENT WAS INITIALLY REPORTED TO BE IN 2006. THIS WAS BEFORE THE PATIENT WAS IMPLANTED WITH THE SUSPECT MEDICAL DEVICE. DATE OF EVENT HAS BEEN CHANGED TO ESTIMATE OF (B)(6), 2009. PATIENT AGE AT THE TIME OF EVENT IS 37 YEARS OLD. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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 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) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH AN UNSPECIFIED MENTOR SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. THE PATIENT BELIEVES THAT HER LEFT BREAST PROSTHESIS HAS DEFLATED. IN ADDITION, THE PATIENT IS FEELING PAIN AND DISCOMFORT IN HER LEFT BREAST. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64340 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5767525

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other| R