BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYSHAPE BREAST IMPLANT

    MDR report key: 11936090 · Received June 3, 2021

    Report

    Report Number
    1645337-2021-06255
    Event Type
    Injury
    Date Received
    June 3, 2021
    Date of Event
    August 3, 2017
    Report Date
    May 10, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317005230
    PMA / PMN Number
    P060028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON DECEMBER 20, 2022, MENTOR BECAME AWARE REGARDING THE DEVICE INFORMATION. HENCE, THE FOLLOWING FIELDS HAVE BEEN UPDATED ON THIS FORM: - FIELD D1 FOR BRAND NAME HAS BEEN UPDATED TO "MENTOR MEMORYSHAPE BREAST IMPLANT" - FIELD D4 FOR CATALOG NUMBER HAS BEEN UPDATED TO "3341352" - FIELD D4 FOR LOT NUMBER HAS BEEN UPDATED TO "6905060" - FIELD D4 FOR SERIAL NUMBER HAS BEEN UPDATED TO (B)(6) - FIELD D4 FOR UNIQUE IDENTIFIER( UDI) HAS BEEN UPDATED TO (B)(4). - FIELD D6A FOR DATE OF IMPLANT HAS BEEN UPDATED TO "OCTOBER 16, 2017" - FIELD G4 FOR PMA/ 510(K) HAS BEEN UPDATED TO "P060028" 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 · 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: AS OF NOW THERE IS NO INFORMATION REGARDING THE EXPLANT OR REOPERATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    THIS EVENT IS ASSOCIATED WITH THE MNT-MEN-15-003 CLINICAL TRIAL, PARTICIPANT (B)(6) . IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH AN UNKNOWN SIZE UNKNOWN GEL IMPLANT ON (B)(6) , 2017. ON (B)(6) , 2018, SHE EXPERIENCED LEFT SIDE CAPSULAR CONTRACTURE; BAKER GRADE IV, WHICH REQUIRED CAPSULECTOMY. 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
    832892 MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3341352 6905060 00081317005230

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other