BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 15742264 · Received November 7, 2022

    Report

    Report Number
    9618003-2022-05312
    Event Type
    Malfunction
    Date Received
    November 7, 2022
    Report Date
    October 13, 2022
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    UDI-DI
    00768455187041
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE 3 OF 13. INITIAL REPORTER NAME AND ADDRESS: COMPLAINANT CITY: (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. FDA REGISTRATION NUMBER: REPORTING SITE: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6 - INVESTIGATION RESULTS UNDER IMDRF CAUSE INVESTIGATION CODE, IMDRF INVESTIGATION FINDINGS, IMDRF CAUSE CONCLUSIONS. H10: INVESTIGATION SUMMARY: BATCH RECORD REVIEW: THE BATCH 7G04286 WAS MANUFACTURED ON 03/AUG/2017, ATS #2 MANUFACTURING LINE, COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 30/DEC/2022 TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED AND NO ISSUES WERE FOUND; ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BILL OF MATERIALS (BOM) AND ALL THE TOOLING INFORMATION DOCUMENTED WAS ALSO CORRECT, SYSTEM APPLICATION PRODUCT (SAP) MATERIAL 1222278 AND MANUFACTURING ORDER (B)(4). THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: TWO PHOTOGRAPHS ASSOCIATED WITH THIS CASE WAS RECEIVED. NO RETURN SAMPLE HAS BEEN RECEIVED FOR THIS COMPLAINT. COMPLAINT DATA ANALYSIS: ON 30/DEC/2022, COMPLAINT INVESTIGATOR PERFORMED A SEARCH OF COMPLAINTS INTO DATABASE SYSTEM FOR LOT NUMBER 7G04286. AS A RESULT, A TOTAL OF ONE COMPLAINT WAS FOUND AND ONLY ONE IS RELATED TO THE SAME MALFUNCTION CODE OF THIS INVESTIGATION. CONCLUSION SUMMARY OF THE RELATED EVENT: BASED ON THE PRELIMINARY INVESTIGATION, NO IRREGULARITIES / DISCREPANCIES WERE FOUND IN ANY OF THE BATCH RECORDS REVIEWED. IN ADDITION, A COMPLAINT SEARCH PERFORMED IN DATABASE SYSTEM BY MANUFACTURING DATE FOR THE ¿STARTER HOLE OFF CENTER OR MISALIGNED¿ FAILURE MODE FOR ATS#1 AND ATS#2 MANUFACTURING LINES SHOWS A DECREASING TREND FROM JUN 2019 TO DATE (CUT OFF 30/SEP/2020). AS PART OF THE NONCONFORMANCE REPORT (NCR) ACTIONS WERE TAKEN FOR THIS FAILURE MODE, WHICH WERE THE MAIN FACTORS FOR THE REDUCTION IN THE QUANTITY OF COMPLAINTS PER MONTH. FURTHERMORE, A NONCONFORMANCE SEARCH WAS PERFORMED IN DATABASE SYSTEM, FROM 2018 TO 30/SEP/2020, FOR THE ¿STARTER HOLE OFF CENTER OR MISALIGNED¿ FAILURE MODE FOR ATS#1 AND ATS#2 MANUFACTURING LINES AND AS A RESULT, NO EVENTS RELATED TO THIS MALFUNCTION WERE FOUND. MOREOVER, THE FOLLOWING QUALITY AND MANUFACTURING CONTROLS ARE CURRENTLY IN PLACE, ACCORDING TO THE PRODUCT INSTRUCTIONS AND TEST METHODS, WHICH CONTRIBUTE DIRECTLY TO THE DETECTION ACTIVITIES: ¿ MANUFACTURING PROCESS INSTRUCTIONS (PI - ATS1 ASSEMBLY AND PACKAGING / PI - ATS2 ASSEMBLY AND PACKAGING) 1. VISUAL INSPECTION TO COMPLETED PRODUCT - 100% OF UNITS 2. TESTING AND INSPECTION LOG ¿ DIMENSIONAL VERIFICATION AND VISUAL INSPECTION LOOKING FOR COLLAR CONCENTRICITY - 6 SAMPLES AT THE BEGINNING OF THE BATCH AND EACH ONE HOUR ¿ QUALITY TEST METHODS (TM - VISUAL NONCONFORMITIES LAMINATED ADHESIVE PRODUCTS / TM - POUCH NONCONFORMITIES) ADDITIONALLY, A NEW QUALITY NOTIFICATION WAS GIVEN TO THE QUALITY AND MANUFACTURING PERSONNEL OF THE ATS#1 AND ATS#2 MANUFACTURING LINES, TO MAKE THEM AWARE OF THE NEW COMPLAINTS RECEIVED FOR THIS FAILURE MODE FOR EVERYTHING EXPLAINED ABOVE, NO ADDITIONAL ACTIONS ARE REQUIRED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, STANDARD OPERATING PROCEDURE (SOP). 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

    IT WAS REPORTED BY END USER THAT THE STARTER HOLE OF THIRTEEN SKIN BARRIERS WAS SLIGHTLY OFF CENTERED. THE PRODUCT WAS NOT USED BY END USER. THERE WAS NO HARM REPORTED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178822 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 411804 7G04286 00768455187041

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown