BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTOURA BREAST TISSUE EXPANDER

    MDR report key: 7213983 · Received January 23, 2018

    Report

    Report Number
    1645337-2018-00543
    Event Type
    Injury
    Date Received
    January 23, 2018
    Date of Event
    December 1, 2017
    Report Date
    January 3, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 07/05/18, IT WAS REPORTED TO MENTOR THAT THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 6943761 HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 07/17/18, IT WAS REPORTED TO MENTOR THAT THE DEVICE EVALUATION AND INVESTIGATION HAVE BEEN COMPLETED. UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITH BROWNISH FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE. WHITE AND GREEN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. UPON VISUAL EXAMINATION, THE DEVICE APPEARS INTACT. LOT NUMBER WAS NOT LEGIBLE. BECAUSE THE AUTHORIZATION FOR RETURN AND EXAMINATION OF MEDICAL DEVICE FORM WAS NOT SIGNED AND/OR RETURNED TO MENTOR, PRODUCT EVALUATION TEAM WAS PRECLUDED FROM FURTHER EVALUATING THE DEVICE. NO OTHER ANOMALIES WERE DISCOVERED. COMPLAINT WAS NOT CONFIRMED. BECAUSE PRODUCT EVALUATION TEAM WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES AND DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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 DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. (B)(4).

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2018, MENTOR RECEIVED ADDITIONAL INFORMATION REGARDING THIS EVENT: THE PROCEDURE TYPE WAS A RECONSTRUCTION REVISION, AND THE COMPLAINT DEVICE WAS A MENTOR ARTOURA TISSUE EXPANDER. PRODUCT DETAILS HAVE BEEN UPDATED ACCORDINGLY. THE DEVICE IMPLANT DATE WAS (B)(6) 2017, AND THE DEVICE WAS FROM THE PATIENT¿S RIGHT SIDE. ADDITIONALLY, ON (B)(6) 2018, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    ON 05/21/18, IT WAS REPORTED TO MENTOR THAT THE DEVICE EVALUATION AND INVESTIGATION HAVE BEEN COMPLETED. UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITH BROWNISH FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE. WHITE AND GREEN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. UPON VISUAL EXAMINATION, THE DEVICE APPEARS INTACT. LOT NUMBER WAS NOT LEGIBLE. BECAUSE THE AUTHORIZATION FOR RETURN AND EXAMINATION OF MEDICAL DEVICE FORM WAS NOT SIGNED AND/OR RETURNED TO MENTOR, PRODUCT EVALUATION TEAM WAS PRECLUDED FROM FURTHER EVALUATING THE DEVICE. NO OTHER ANOMALIES WERE DISCOVERED. COMPLAINT WAS NOT CONFIRMED. BECAUSE PRODUCT EVALUATION TEAM WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH AN UNKNOWN MENTOR TISSUE EXPANDER THAT DEFLATED AFTER IMPLANTATION. IT WAS REPORTED THAT THE TISSUE EXPANDER HAD A LEAK, RESULTING IN THE DEFLATION. NO FURTHER INFORMATION IS KNOWN ABOUT THE DEVICE AT THIS TIME. THE DATE OF IMPLANT IS ALSO UNKNOWN, AND THE DATE OF EXPLANT WAS SOMETIME IN (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55149 ARTOURA BREAST TISSUE EXPANDER EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS 6943761

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention