BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS

    MDR report key: 20158769 · Received September 6, 2024

    Report

    Report Number
    1645337-2024-10383
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    January 1, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    UDI-DI
    00081317006718
    PMA / PMN Number
    K130813
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    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. 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: INFECTION. D4: FULL UDI CURRENTLY UNAVAILABLE SINCE THE EXACT SERIAL NUMBER OF THE SUSPECTED DEVICE CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 275CC TISSUE EXPANDERS AND PRESENTED WITH AN INFECTION WITH AN ATYPICAL MYCOBACTERIUM IN ONE OF HER BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNKNOWN DATE. INFORMATION ABOUT TWO DEVICES WERE REPORTED: LEFT BREAST: CATALOG #: 3549211, LOT #: 9892897, SERIAL #: (B)(6). RIGHT BREAST: CATALOG #: 3549211, LOT #: 9892897, SERIAL #: (B)(6). THE SIDE OF THE INFECTION (LEFT BREAST, RIGHT BREAST, OR BILATERAL) WAS NOT SPECIFIED. IF CLARIFICATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2139643 MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS 9892897 00081317006718

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention