BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GEL IMPLANTS

    MDR report key: 15717012 · Received November 2, 2022

    Report

    Report Number
    1645337-2022-13259
    Event Type
    Injury
    Date Received
    November 2, 2022
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, 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 COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE, CANCER. MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION: AFTER CLINICAL/SECONDARY REVIEW OF THIS FILE PERFORMED ON (B)(6) 2022, IT WAS DECIDED TO REMOVE HEALTH EFFECT - CLINICAL CODE CODE CANCER (E1801) AND REPLACE WITH CODE BREAST CANCER (E180101) TO MORE ACCURATELY CAPTURE THE REPORTED EVENT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4) H6 HEALTH EFFECT - CLINICAL CODE: REPLACED CANCER (E1801) WITH BREAST CANCER (E180101).

    Description of Event or Problem · 0

    IT WAS REPORTED (VIA FDA MW5112019) THAT A FEMALE PATIENT WHO UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO UNSPECIFIED MENTOR GEL IMPLANTS, DEVELOPED BREAST CANCER IN THE LEFT BREAST, POST-OPERATIVELY. ADDITIONALLY, THE PATIENT DEVELOPED CAPSULAR CONTRACTURE IN BOTH BREASTS AND FURTHER SCARRING FROM THE RADIATION TREATMENTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION, A PARTIAL MASTECTOMY AND BREASTS RECONSTRUCTION ON (B)(6) 2022. AT THIS TIME, THE RESULTS OF THE PATHOLOGY REPORT HAVE NOT BEEN PROVIDED. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275775 UNKNOWN GEL IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention