BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTOURA BREAST TISSUE EXPANDER

    MDR report key: 9907689 · Received March 31, 2020

    Report

    Report Number
    1645337-2020-05109
    Event Type
    Injury
    Date Received
    March 31, 2020
    Report Date
    March 10, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    PMA / PMN Number
    K161176
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 07-APR-2020, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: - THE PATIENT IDENTIFIER IS (B)(6). - THE SUSPECT MEDICAL DEVICE IS AN ARTOURA BREAST TISSUE EXPANDER 850CC DEVICE, CATALOG #, LOT #7680126, SERIAL #(B)(6), UDI #(B)(4), 510(K) #K161176. 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 IMPLANTATION DATE IS (B)(6) 2019. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH AN UNSPECIFIED MENTOR TISSUE EXPANDER THAT DEFLATED AFTER IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368037 ARTOURA BREAST TISSUE EXPANDER EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS 7680126

    Patients

    Seq Age Sex Outcome Treatment
    1 Other