BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS

    MDR report key: 7852908 · Received September 6, 2018

    Report

    Report Number
    1645337-2018-05408
    Event Type
    Injury
    Date Received
    September 6, 2018
    Date of Event
    April 1, 2018
    Report Date
    August 13, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    UDI-DI
    00081317006817
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    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. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 650CC IMPLANTS WHICH THE RIGHT SIDE FAILED TO INFLATE AFTER INITIAL INFLATION AND SIX WEEKS AFTER IMPLANTATION. AS A RESULT PATIENT HAD THE EXPANDER REMOVED AND REPLACED WITH ALLERGAN DEVICE AS FOLLOW: CATALOG NUMBER TCM-375, LOT NUMBER 2993976, SERIAL NUMBER (B)(4) ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691671 MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS 6797947 00081317006817

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention