BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MENTOR GEL IMPLANTS

    MDR report key: 19014046 · Received April 1, 2024

    Report

    Report Number
    1645337-2024-03963
    Event Type
    Injury
    Date Received
    April 1, 2024
    Date of Event
    July 1, 2023
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED MENTOR DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNKNOWN MENTOR. THIS QUARTERLY REPORT CAPTURES ALL THE DATA (INCLUDING PATIENT DEMOGRAPHICS, PATIENT MEDICAL HISTORY, PROCEDURAL INFORMATION, DEVICE INFORMATION AND RE-OPERATION INFORMATION) SUBMITTED TO THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) FROM JULY 1, 2023, THROUGH SEPTEMBER 30, 2023. 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: NA. 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).

    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. THIS QUARTERLY REPORT CAPTURES ALL THE DATA (INCLUDING PATIENT DEMOGRAPHICS, PATIENT MEDICAL HISTORY, PROCEDURAL INFORMATION, DEVICE INFORMATION AND RE-OPERATION INFORMATION) SUBMITTED TO THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) FROM JULY 1, 2023, THROUGH SEPTEMBER 30, 2023. THE TABLES LABELED ¿RE-OPERATION INFORMATION¿ (PG. 25-27) INDICATE REASONS, COMPLICATIONS, DEVICE PROBLEMS, AND PATIENT REQUESTS THAT LEAD TO RE-OPERATIONS INVOLVING MENTOR IMPLANTS VS NON-MENTOR IMPLANTS FROM JULY 1, 2023, THROUGH SEPTEMBER 30, 2023. ADVERSE EVENT(S) REPORTED FOR MENTOR IMPLANTS ASSOCIATED WITH RE-OPERATION FROM JULY 1, 2023, THROUGH SEPTEMBER 30, 2023: QTY UNK: CAPSULAR CONTRACTURE (89.04%). QTY UNK: HEMATOMA (2.05%). QTY UNK: INFECTION (4.11%). QTY UNK: SEROMA (1.37%). QTY UNK: SKIN NECROSIS (0.68%). QTY UNK: WOUND PROBLEMS (2.74%). QTY UNK: DEVICE MIGRATION/MALPOSITION (28.00%). QTY UNK: SUSPECTED/ACTUAL RUPTURE/DEFLATION (56.00%). QTY UNK: WRINKLING/RIPPLING (16.00%). QTY UNK: CHANGE SHAPE/SIZE/STYLE (59.78%). QTY UNK: CORRECTION OF ASYMMETRY (26.66%). QTY UNK: PTOSIS (13.25%). QTY UNK: NEED FOR BIOPSY/TUMOR (6.90%). QTY UNK: OTHER (62.07%). QTY UNK: OTHER CANCER (24.14%). QTY UNK: RECURRENT CANCER (6.90%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590445 UNKNOWN MENTOR GEL IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention