BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR CPX 2 BREAST TISSUE EXPANDER

    MDR report key: 6811091 · Received August 22, 2017

    Report

    Report Number
    1645337-2017-00056
    Event Type
    Malfunction
    Date Received
    August 22, 2017
    Date of Event
    June 14, 2016
    Report Date
    October 31, 2016
    Manufacturer
    MENTOR WORLDWIDE LLC
    Product Code
    LCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: THE PRODUCT WAS RETURNED WITHOUT THE BOX WITH THE SUSPECT SEAL. AS A RESULT, THE COMPLAINT CANNOT BE CONFIRMED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 6973253 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. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT 6973253 IDENTIFIED NO IRREGULARITIES AND NO NCR¿S REFERENCE IN THE DHR ASSOCIATED WITH THE RELEASE OF THIS LOT. A REVIEW OF THE COMPLAINT DATABASE REVEALED NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. AS A RESULT, WE ARE CLOSING THIS INVESTIGATION. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 6973253 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 REF. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGING OF ENCLOSING A TISSUE EXPANDER WAS NOTED TO BE UNSEALED DURING A PROCEDURE. THE PRODUCT WAS USED ON THE PATIENT. THIS PRODUCT IS MEANT TO BE KEPT STERILE BEFORE IT IS USED ON THE PATIENT. IF THE SEAL THAT HOLDS THE PACKAGING OF THE PRODUCT IS COMPROMISED, AND THE PRODUCT IS USED ON THE PATIENT, THIS CREATES THE RISK OF INFECTION. INFECTION LEAD TO ISSUES SUCH AS SEPSIS OR THE NEED FOR ADDITIONAL SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGING OF ENCLOSING A TISSUE EXPANDER WAS NOTED TO BE UNSEALED DURING A PROCEDURE. THE PRODUCT WAS USED ON THE PATIENT. THIS PRODUCT IS MEANT TO BE KEPT STERILE BEFORE IT IS USED ON THE PATIENT. IF THE SEAL THAT HOLDS THE PACKAGING OF THE PRODUCT IS COMPROMISED, AND THE PRODUCT IS USED ON THE PATIENT, THIS CREATES THE RISK OF INFECTION. INFECTION LEAD TO ISSUES SUCH AS SEPSIS OR THE NEED FOR ADDITIONAL SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592203 MENTOR CPX 2 BREAST TISSUE EXPANDER EXPANDER, SKIN, INFLATABLE LCJ MENTOR WORLDWIDE LLC 6973253-043

    Patients

    Seq Age Sex Outcome Treatment
    1