BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 8499897 · Received April 10, 2019

    Report

    Report Number
    9618003-2019-02606
    Event Type
    Malfunction
    Date Received
    April 10, 2019
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    UDI-DI
    00768455187034
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: D4: UNIQUE IDENTIFIER (UDI) H6: INVESTIGATION RESULTS UNDER IMDRF CAUSE INVESTIGATION CODE, IMDRF INVESTIGATION FINDINGS, IMDRF CAUSE CONCLUSIONS H10: INVESTIGATION SUMMARY RETURNED SAMPLE EVALUATION: THERE ARE THREE (3) PHOTOGRAPHS ASSOCIATED WITH THIS CASE AND IN THESE, THE REPORTED DEFECT CAN BE OBSERVED. NO UNUSED RETURNED SAMPLE WAS RECEIVED. CONCLUSION SUMMARY OF THE RELATED EVENT: BASED ON THE ANALYSIS PERFORMED, EVEN THOUGH THERE WAS AN INCREASING TENDENCY OF COMPLAINTS RELATED TO ¿OFF CENTER STARTER HOLE¿ DURING 2018 AND BEGINNING OF 2019, THE UPDATED DATA SHOWS A POSITIVE TENDENCY AFTER THE CORRECTIONS EXECUTED TO THE ATS#1 AND ATS#2 MACHINES. CURRENT QUALITY AND MANUFACTURING CONTROLS HAVE DEMONSTRATED TO BE ADEQUATE AND EFFECTIVE SINCE NO NON-CONFORMANCES HAVE BEEN GENERATED DURING THE PRODUCTION PROCESS ASSOCIATED TO THE SAME FAILURE FROM (B)(6) TO (B)(6) 2020. ALSO, THIS FAILURE MODE WILL CONTINUE TO BE MONITORED BY THE LEADERSHIP DURING THE CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEW BOARD (MONTHLY) AND MANAGEMENT REVIEW (BIANNUAL) FOR TRACK AND TRENDING. NO ADDITIONAL ACTION IS CONSIDERED NECESSARY FOR THIS RECORD. THE INVESTIGATION ASSOCIATED WITH RELATED EVENT HAS BEEN APPROVED AND IS COMPLETE. NO ADDITIONAL ACTION IS REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 1049092. MANUFACTURING SITE: 9618003.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE END USER REPORTED THE STARTER HOLE IS NOT IN THE CENTER AND IS NOT USABLE. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE REPORTED ISSUE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293098 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 411803 8D04825 00768455187034

    Patients

    Seq Age Sex Outcome Treatment
    1 Male