BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYSHAPE¿ TH 680CC

    MDR report key: 11287684 · Received February 5, 2021

    Report

    Report Number
    1645337-2021-01181
    Event Type
    Injury
    Date Received
    February 5, 2021
    Date of Event
    March 3, 2021
    Report Date
    January 15, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317024262
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021 ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT EXPERIENCED LEFT SIDED SEROMA ON (B)(6) 2021, SHE HAD BACTRIM, AND UNSPECIFIED SECONDARY PROCEDURE AND THE ISSUE WAS RESOLVED, THEN ANOTHER EPISODE OF SEROMA ON (B)(6) 2021, WHICH THE IMPLANT WAS REMOVED AND REPLACED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, MENTOR BECAME AWARE THAT THE INITIAL REPORTER: ( MANUFACTURER REPORT NUMBER 1645337-2021-01181, HAS TYPO ERROR ON D2B SECTION. ON (B)(6) 2021, ADDITIONAL INFORMATION RECEIVED INDICATED THAT DUE TO WOUND INFECTION ON THE LEFT SIDE, PATIENT HAD THE LEFT IMPLANT REPLACED WITH ANOTHER IMPLANT WITH CAT#: 3451234, SN#: (B)(6), ON (B)(6) 2021. MANUFACTURER¿S REFERENCE NUMBER: (B)(4). 2B. PROCODE: FTR.

    Additional Manufacturer Narrative · 0

    PER ADDITIONAL INFORMATION RECEIVED ON OCTOBER 20, 2022 PATIENT HAD ANOTHER ONSET OF SEROMA ON (B)(6) 2021. PATIENT UNDERWENT, SECONDARY PROCEDURE ON (B)(6) 2020, WHICH RESOLVED THE ISSUE. MEMORYSHAPE CATALOG NUMBER: 334-1404 SERIAL NUMBER: (B)(6), CATALOG NUMBER: 334-1404 SERIAL NUMBER: (B)(6). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON JUNE 28, 2021 MENTOR BECAME AWARE THAT UNINTENTIONALLY MISSED REPORTING PATIENTS¿ WEIGHT AND IDENTIFIER IN INITIAL REPORT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4). A4 PATIENT WEIGHT: 135 LB, AND A1 PATIENT IDENTIFIER: (B)(6).

    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: NA. (B)(4). IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. MANUFACTURERS REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYSHAPE 680CC SILICONE PROSTHESIS EXPERIENCED LEFT SIDED SEROMA POST PROCEDURE. AS A RESULT, DOCTOR PERFORMED INCISION FOR THE DRAINAGE, AND THE ISSUE WAS RESOLVED. 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
    183180 MENTOR MEMORYSHAPE¿ TH 680CC PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3341404 9491403 00081317024262

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention