BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR CPX4 WITH SUTURE TABS, TALL HEIGHT, SMOOTH

    MDR report key: 9236166 · Received October 24, 2019

    Report

    Report Number
    1645337-2019-22539
    Event Type
    Injury
    Date Received
    October 24, 2019
    Date of Event
    August 21, 2019
    Report Date
    September 26, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    PMA / PMN Number
    K182335
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 11/06/2019, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: - THE SUSPECT MEDICAL DEVICE IS A MENTOR CPX4 WITH SUTURE TABS, TALL HEIGHT, SMOOTH 550CC TISSUE EXPANDER, CATALOG #3509314, LOT #7653729, SERIAL #(B)(4) UDI #(B)(4), 510(K) #K182335. 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. - THE EVENT DATE WAS INITIALLY REPORTED TO BE (B)(6) 2019. NEW INFORMATION RECEIVED STATES THAT IT WAS AROUND (B)(6) 2019. - THE IMPLANTATION DATE WAS INITIALLY REPORTED TO BE (B)(6) 2019. NEW INFORMATION STATES THAT THE IMPLANTATION DATE IS (B)(6) 2019. - THE EXPLANTATION DATE WAS INITIALLY REPORTED TO BE (B)(6) 2019. NEW INFORMATION STATES THAT THE EXPLANTATION DATE IS (B)(6) 2019. - THE PATIENT IDENTIFIER IS T.E., DATE OF BIRTH IS (B)(6) 1976, PATIENT AGE THE TIME OF EVENT IS 42 YEARS OLD, AND SEX IS FEMALE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEEN DISCARDED. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION OF TISSUE EXPANDER. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH AN UNSPECIFIED MENTOR TISSUE EXPANDER THAT DEFLATED AFTER IMPLANTATION. THE DEFLATION WAS OBSERVED WHERE THE SEAM MEETS THE TAB ON THE DEVICE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029600 MENTOR CPX4 WITH SUTURE TABS, TALL HEIGHT, SMOOTH EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS 7653729

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention