BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 16129210 · Received January 10, 2023

    Report

    Report Number
    9618003-2023-00074
    Event Type
    Malfunction
    Date Received
    January 10, 2023
    Report Date
    December 16, 2022
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    UDI-DI
    00768455187027
    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: H6 - INVESTIGATION RESULTS UNDER IMDRF CAUSE INVESTIGATION CODE, IMDRF INVESTIGATION FINDINGS, IMDRF CAUSE CONCLUSIONS. C22 AND D17 WERE SELECTED UNDER IMDRF INVESTIGATION FINDINGS AND IMDRF CAUSE CONCLUSIONS RESPECTIVELY BECAUSE THEY ARE NOT ADEQUATELY DESCRIBED BY ANY OTHER TERM FOR "AN OVER THE TIME FADE ON THE CRITERIA FOR THE DECENTRALIZATION DEFECTS AND THE CORRECT USE OF THE TOOLING AVAILABLE ON THE LINE". BATCH RECORD REVIEW: LOT 2E04310 WAS MANUFACTURED ON 31/MAY/2022, IN ATS #2 LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). COMPLIANCE ENGINEER PERFORMED A BATCH RECORD REVIEW ON 29/MAR/2023, 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 IDENTIFICATION 1222277 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: THERE ARE PHOTOGRAPHS ASSOCIATED WITH THIS CASE AND IN THESE, THE REPORTED DEFECT CAN BE SEEN. NO UNUSED RETURN SAMPLE WAS EXPECTED. CONCLUSION SUMMARY OF THE RELATED EVENT: DURING THE EVENT SUMMARY AND IMPACT EVALUATION OF THIS NONCONFORMANCE REPORT (NCR), WITH THE SUPPORT OF THE TRIAGE TEAM EXPERTISE, THE MOST PROBABLE CAUSES OF THE PROBLEM IDENTIFIED: AFTER PERFORMING THE ROOT CAUSE ANALYSIS, IT WAS CONCLUDED THAT THE NON-CONFORMANCE IS RELATED TO AN OVER THE TIME FADE ON THE CRITERIA FOR THE DECENTRALIZATION DEFECTS AND THE CORRECT USE OF THE TOOLING AVAILABLE ON THE LINE. THE APPROPRIATE ACTIONS WILL BE TAKEN THROUGH THE CORRECTIVE/PREVENTATIVE ACTION (CAPA). THE INVESTIGATION ASSOCIATED WITH RELATED EVENT WAS APPROVED AND 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.

    Additional Manufacturer Narrative · 0

    13 OF 20. COMPLAINANT STATE/PROVINCE: (B)(6). COMPLAINANT PHONE: (B)(6). COMPLAINANT COUNTRY: KOREA, REPUBLIC OF. 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). MANUFACTURING SITE: (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    THE END USER REPORTED THAT STARTER HOLE WAS OFF CENTERED FOR ALL TWENTY WAFERS. THE PRODUCT WAS NOT USED BY END USER, THEREFORE, THERE WAS NO HARM EXPERIENCED BY END USER. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188912 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 411802 2E04310 00768455187027

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown