BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 22714385 · Received August 5, 2025

    Report

    Report Number
    9618003-2025-02260
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    July 8, 2025
    Report Date
    July 11, 2025
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    UDI-DI
    00768455187003
    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 TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY: BATCH RECORD REVIEW: LOT: 4G04818 WAS MANUFACTURED 23/JULY/2024, IN ATS #2 LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINTS INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 04/AUG/2025, 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 (ID): 1222276 AND MANUFACTURING ORDER: (B)(4). REVIEW OF THE BATCH RECORD SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DISCREPANCY RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION. THE DEFECT REPORTED BY THE CUSTOMER COULD OCCUR DURING THE SUB-ASSEMBLY PROCESS PERFORMED IN THE DELTA CRUSADER MANUFACTURING LINE. FOR THIS REASON, A DETAILED BATCH RECORD REVIEW WAS PERFORMED OF THE SUBASSEMBLY LOT MANUFACTURED IN THIS LINE. THE SUBASSEMBLY LOT: 4G0426206, ORDER: (B)(4), MATERIAL: 1216906, WAS MANUFACTURED ON 25/JULY/2024 IN THE DELTA CRUSADER MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EAS). THE COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 04/AUG/2025 AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE COMPONENTS FOR ASSEMBLY WERE CORRECT AS PER BILL OF MATERIALS (BOM) AND THE EQUIPMENT SETTINGS WERE THE APPLICABLE ONES. THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. THE SUBASSEMBLY LOT: 4H0157103, ORDER: (B)(4), MATERIAL: 1216906, WAS MANUFACTURED ON 13/AUG/2024 IN THE DELTA CRUSADER MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EAS). THE COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 04/AUG/2025 AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE COMPONENTS FOR ASSEMBLY WERE CORRECT AS PER BILL OF MATERIALS (BOM) AND THE EQUIPMENT SETTINGS WERE THE APPLICABLE ONES. THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: THERE WERE PHOTOGRAPHS ASSOCIATED WITH THIS CASE AND IN THESE, THE REPORTED DEFECT CAN BE SEEN. NO UNUSED RETURN SAMPLE WAS EXPECTED. HISTORICAL COMPLAINTS REVIEW: ON 04/AUG/2025, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE 4G04818 LOT FOR THE MALFUNCTION ¿SKIN BARRIER MIGRATES AND OBSTRUCTS STOMA¿ DEFECT AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED. HISTORICAL NONCONFORMANCE REVIEW: ON 04/AUG/2025, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CAPA (S) ASSOCIATED TO THE MALFUNCTION ¿SKIN BARRIER MIGRATES AND OBSTRUCTS STOMA¿ DEFECT FOR THE LOT NUMBER: 4G04818 AND AS RESULT, NO NON-CONFORMANCE (NC)'S / CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) (S) FOR THIS MALFUNCTION WERE GENERATED DURING THE MANUFACTURING PROCESS OF THE REFERENCED LOT. CURRENT QUALITY CONTROLS: BASED ON THE PROCESS INSTRUCTION (PI), THE FOLLOWING TESTS WERE PERFORMED IN THE MANUFACTURING LINES, IN ORDER TO IDENTIFY THIS FAILURE MODE IN OUR MANUFACTURING PROCESS: TEST METHODS (TM)-017 "VISUAL NONCONFORMITIES": FREQUENCY: HOURLY, SAMPLE QUANTITY: 2 SAMPLES, ACCEPTANCE CRITERIA: ACCEPT = 0 / REJECT = 1. DEFECT RATE ANALYSIS: THERE HAVE ONLY BEEN 3 DEFECTIVE PARTS CONFIRMED TO DATE FROM A LOT SIZE OF (B)(4) PRODUCTS. THIS REPRESENTS A DEFECT RATE OF ONLY (B)(4), WHICH IS WELL WITHIN AN APPROPRIATE ACCEPTABLE QUALITY LEVEL (AQL) FOR THIS DEFECT WHICH SHOULD BE 0.25% BASED ON OUR STANDARD OPERATING PROCEDURE (SOP). IN ADDITION, ALL OF THE IN-PROCESS TESTING ON THIS LOT DID NOT FIND A SINGLE DEFECTIVE UNIT, WHICH CONFIRMS THAT THE LOT IS UNLIKELY TO BREACH AN ACCEPTABLE QUALITY LEVEL (AQL) OF 0.25. TO DATE, IT IS WELL WITHIN OUR ACCEPTED ACCEPTABLE QUALITY LEVEL (AQL) FOR THIS TYPE OF FAILURE MODE OR DEFECT. CONCLUSION: THERE WERE PHOTOGRAPHS ASSOCIATED WITH THIS CASE AND IN THESE, THE REPORTED DEFECT CAN BE SEEN. A REVIEW OF BATCH RECORDS WAS COMPLETED AND SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DISCREPANCIES RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION, AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED. 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: 9618003, MANUFACTURING SITE: 9618003.

    Additional Manufacturer Narrative · 0

    DEVICE 3 OF 3. E1: COMPLAINANT COUNTRY: CHINA. 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: 1049092 MANUFACTURING SITE: 9618003.

    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 THE BOX OF THREE SKIN BARRIERS HAD A SERIOUS MASS MELTING PROBLEM, WHICH HAD ALSO BLOCKED THE EXCRETION OUTLET. IT HAD BEEN CONFIRMED THAT OBSTRUCTION HAD FULLY BLOCKED THE STOMA. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2804936 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 411800 4G04818 00768455187003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown