BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MENTOR

    MDR report key: 16053494 · Received December 27, 2022

    Report

    Report Number
    1645337-2022-15479
    Event Type
    Injury
    Date Received
    December 27, 2022
    Date of Event
    January 1, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED MENTOR DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNKNOWN MENTOR SINCE APRIL 2015, THE DUTCH BREAST IMPLANT REGISTRY (DBIR) HAS BEEN REGISTERING CHARACTERISTICS OF PATIENTS, SURGICAL PROCEDURES, AND BREAST IMPLANTS TO MONITOR, BENCHMARK, AND IMPROVE THE QUALITY OF BREAST IMPLANT SURGERY IN THE NETHERLANDS. TABLE 11 (PG. 37) SHOWS THE INDICATIONS FOR REVISION & PERIOPERATIVE FINDINGS, RECONSTRUCTIVE PERMANENT IMPLANTS (2021). MULTIPLE ISSUES CAN BE REGISTERED PER REVISION, EITHER AS THE REASON FOR REVISION OR FOUND INCIDENTALLY DURING THE REVISION PROCEDURE. ADVERSE EVENT(S): QTY 53(16.5%): ASYMMETRY QTY 52 (16.2%): DEVICE MIGRATION/MALPOSITION QTY 43 (13.4%): BREAST PAIN QTY 38 (11.8%): CAPSULAR CONTRACTURE QTY 38 (11.8%): DEEP WOUND INFECTION QTY 37 (11.5%): SKIN NECROSIS OR DEHISCENCE QTY 26 (8.1%): DISSATISFIED WITH VOLUME QTY 26 (8.1%): SEROMA QTY 14 (4.4%): SKIN SCARRING QTY 10 (3.1%): BREAST CANCER QTY 8 (2.5%): FLAP PROBLEM QTY 6 (1.9%): SUSPICION OF BREAST IMPLANT ASSOCIATED ILLNESS QTY 6 (1.9%): HEMATOMA QTY 1 (0.3%): DEVICE RUPTURE OR DEFLATION QTY 1 (0.3%): SILICONE EXTRAVASATION QTY 1 (0.3%): BIA-ALCL (SUSPICION) THE TYPE OF DEVICE INVOLVED IS UNKNOWN, AND THE GEL COMMON DEVICE NAME/PROCODE VALUES ARE BEING USED FOR SUBMISSION PURPOSES ONLY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF CLARIFYING INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444482 UNKNOWN MENTOR PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention