BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS

    MDR report key: 7444635 · Received April 19, 2018

    Report

    Report Number
    1645337-2018-02343
    Event Type
    Malfunction
    Date Received
    April 19, 2018
    Date of Event
    March 21, 2018
    Report Date
    March 23, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    UDI-DI
    00081317006718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MENTOR FAILURE ANALYSIS LAB HAS 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. THE DEVICE HISTORY RECORD (DHR) 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    UPON RECEIPT BY MENTOR, THE DEVICE CONTAINED FLUID WITH CLEAR APPEARANCE. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE. GEL WAS OBSERVED ON THE SHELL SURFACE. DURING VISUAL EXAMINATION, PRODUCT EVALUATION OBSERVED THE DEVICE APPEARS INTACT. BECAUSE THE AUTHORIZATION FOR RETURN AND EXAMINATION OF MEDICAL DEVICE FORM WAS NOT SIGNED AND/OR RETURNED TO MENTOR, PRODUCT EVALUATION WAS PRECLUDED FROM FURTHER EVALUATING THE DEVICE. NO ANOMALIES WERE FOUND. THE COMPLAINT OF DEFLATION WAS NOT CONFIRMED SINCE NO ANOMALIES WERE FOUND ON THE REPORTED DEVICE. AT THIS POINT, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE MATERIAL OBSERVED ON THE SHELL SURFACE. MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE. THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 6843607 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. BECAUSE THE RISK OF DEVICE DEFLATION CANNOT BE ELIMINATED, MENTOR ADDRESSES THIS RISK IN THE PIDS BY STATING THAT THESE DEVICES SHOULD NOT BE CONSIDERED LIFETIME DEVICES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-OPERATION WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 275CC, THE DOCTOR NOTICED THAT THE IMPLANT EXPANDER HAD A HOLE AND WAS LEAKING. THE EVENT WAS ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287325 MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS 6843607 00081317006718

    Patients

    Seq Age Sex Outcome Treatment
    1