BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 10027047 · Received May 5, 2020

    Report

    Report Number
    1645337-2020-06083
    Event Type
    Injury
    Date Received
    May 5, 2020
    Date of Event
    April 11, 2020
    Report Date
    April 15, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020 "LABELED FOR SINGLE USE? NO" WAS ERRONEOUSLY SUBMITTED IN INITIAL REPORT. THE CORRECTION SHOULD BE YES FOR LABELED FOR SINGLE USE?. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, MENTOR BECAME AWARE OF PATIENT'S IMPACTED PRODUCT, A 400CC MENTOR MEMORYGEL BREAST IMPLANT SERIAL CATALOG (B)(6),SERIAL NUMBER (B)(6), LOT NUMBER 6760812. 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. MANUFACTURER¿¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON JANUARY 6, 2022, MENTOR BECAME AWARE THAT PATIENT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III POST PROCEDURE.

    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 HISPANIC FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH AN UNSPECIFIED SMOOTH GEL BREAST IMPLANT EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE BAKER GRADE II POST PROCEDURE. 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
    487733 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6760812

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other