BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR TISSUE EXPANDER

    MDR report key: 7809292 · Received August 23, 2018

    Report

    Report Number
    1645337-2018-05144
    Event Type
    Injury
    Date Received
    August 23, 2018
    Date of Event
    June 25, 2018
    Report Date
    August 7, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    UDI-DI
    00081317002468
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE DEVICE WAS RECEIVED AT MENTOR WITHOUT FLUID. YELLOW MATERIAL WAS OBSERVED WITHIN THE DEVICE. NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. THE PRODUCT EVALUATION TEAM DISCOVERED A RENT AT THE PATCH JUNCTION. MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT GAVE NO INDICATIONS AS TO CAUSE. NO OTHER ANOMALIES WERE DISCOVERED. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE OR THE ETIOLOGY OF THE YELLOW MATERIAL FOUND ON THE DEVICE. THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 6991656 WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. 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

    THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 8/21/2018. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATION AND ANALYSIS HAVE BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED ON 8/14/2018, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH A MENTOR 550CC BREAST TISSUE EXPANDER ON THE LEFT BREAST EXPERIENCED DEFLATION POST PROCEDURE. IT WAS NOTED THE TISSUE EXPANDER HAD A PERFORATION IN THE OPPOSITE PORTION OF THE VALVE, AT THE BORDER BETWEEN THE SILICONE AND THE RIGID BASE OF THE DEVICE. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A SIMILAR MENTOR 550CC BREAST TISSUE EXPANDER ON (B)(6) 2018; CATALOG # 3504310M, S/NS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651294 MENTOR TISSUE EXPANDER EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS 6991656 00081317002468

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention