BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8875970 · Received August 8, 2019

    Report

    Report Number
    1645337-2019-16713
    Event Type
    Injury
    Date Received
    August 8, 2019
    Date of Event
    June 1, 2010
    Report Date
    July 25, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000686
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON OCTOBER 26, 2020, MENTOR BECAME AWARE THAT THE DATE OF REMOVAL SURGERY WAS (B)(6) 2020, AND PATIENT ALSO EXPERIENCED RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN. HENCE, FOLLOWING FIELDS HAVE BEEN UPDATED ON THIS FORM: - IS REQUIRED INTERVENTION HAS BEEN SELECTED UNDER SECTION B; FIELD B2, - FIELD D7 EXPLANTATION DATE HAS BEEN UPDATED TO (B)(6) 2020, - FIELD H6 PATIENT CODE "CAPSULAR CONTRACTURE" AND "NO CODE AVAILABLE" HAS BEEN ADDED, - FIELD H6 METHOD CODE HAS BEEN UPDATED TO "DEVICE NOT RETURNED". H6 PATIENT CODE 3191: MEDICAL DEVICE REMOVAL. 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. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: AS OF NOW THERE IS NO INFORMATION REGARDING THE EXPLANT OR REOPERATION. CONCOMITANT PRODUCTS: LEFT SIDE; 325CC MENTOR MEMORYGEL BREAST IMPLANT; CATALOG NUMBER: 3543257; LOT NUMBER: 223437. MANUFACTURER¿S REFERENCE NUMBER: (B)(4). L) 354-3257, LOT# 223437.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 325CC MENTOR MEMORYGEL BREAST IMPLANT AND WAS PRESENTED WITH HARD MASS ON THE RIGHT BREAST, DISCOMFORT, BREAST PAIN AND RASH ON THE RIGHT SIDE. ALSO RIGHT IMPLANT APPEARS LARGER. 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
    668520 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3543257 197619 00081317000686

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other| R