BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND HIGH PROFILE

    MDR report key: 10519221 · Received September 10, 2020

    Report

    Report Number
    1645337-2020-11403
    Event Type
    Injury
    Date Received
    September 10, 2020
    Date of Event
    January 1, 2019
    Report Date
    August 19, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON SEPTEMBER 18, 2020, MENTOR BECAME AWARE THAT THE SUSPECT MEDICAL DEVICES ARE THE FOLLOWING: (LEFT) 420CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE CATALOG: 3503420 LOT: 6884005 SN: (B)(6) AND (RIGHT) 420CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE CATALOG: 3503420 LOT: 6884005 SN: (B)(6). MENTOR ALSO BECAME AWARE THAT THE CORRECT BAKER GRADES FOR THE BREAST ARE THE FOLLOWING: LEFT - BAKER GRADE III AND RIGHT - BAKER GRADE IV. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE COMPLAINT DEVICE. AS A RESULT, THE MANUFACTURING DATE AND EXPIRATION DATE FIELDS HAVE BEEN UPDATED. THE MANUFACTURING RECORD EVALUATION (MRE) WAS REVIEWED, 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

    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 MANUFACTURING RECORD EVALUATION REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: N/A. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO UNSPECIFIED MENTOR SALINE BREAST PROSTHESES, EXPERIENCED, TON OF PAIN, MISSHAPED IMPLANTS, PAIN UNDER LEFT ARMPIT THAT IS SO SEVERE THAT THEY CANNOT EVEN VACUUM OR WORK OUT. IT WAS CONFIRMED THAT THE PATIENT SUFFERED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE IV ON THE LEFT AND BAKER GRADE III ON THE RIGHT SIDE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980621 MENTOR SMOOTH ROUND HIGH PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6884005

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other