BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 23377427 · Received October 24, 2025

    Report

    Report Number
    9618003-2025-02838
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Report Date
    October 14, 2025
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE 8 OF 10 E1: COMPLAINANT STREET ADDRESS: (B)(6) COMPLAINANT COUNTRY: CANADA. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: ¿THERE WAS A PHOTOGRAPH ASSOCIATED WITH THIS CASE AND IN THIS, THE REPORTED DEFECT CAN BE SEEN. NO UNUSED RETURN SAMPLE WAS EXPECTED. BATCH RECORD REVISION RESULTS: LOT 3J03051 WAS MANUFACTURED ON 20/SEP/2023, IN ATS #1 LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 22/OCT/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) 1222277 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. HISTORICAL COMPLAINTS REVIEW: ON 22/OCT/2025, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE 3J03051 LOT FOR THE MALFUNCTION ¿SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G MISALIGNMENT OR OFF CENTER), LEAKAGE MAY OCCUR (MOLDABLE ONLY)¿ DEFECT AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED. HISTORICAL NONCONFORMANCE REVIEW: ON 22/OCT/2025, THE COMPLAINT INVESTIGATOR ID (B)(4) RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NON-CONFORMANCE (NC)'S / CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) (S) ASSOCIATED TO THE MALFUNCTION ¿SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G MISALIGNMENT OR OFF CENTER), LEAKAGE MAY OCCUR (MOLDABLE ONLY)¿ FOR THE LOT NUMBER 3J03051 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 ARE PERFORMED IN THE MANUFACTURING LINES, IN ORDER TO IDENTIFY THIS FAILURE MODE IN OUR MANUFACTURING PROCESS: DIMENSIONAL INSPECTION: FILM RELEASE LINER: THE FILM MUST REMAIN INTACT ALONG THE LENGTH OF THE WAFER WITHOUT ANY CUTS IN THE CENTER HOLE. THE FILM RELEASE TAB MUST BE FREE AND NOT BE TRAPPED UNDER THE ADHESIVE DISK. FREQUENCY: HOURLY SAMPLE QUANTITY: 3 SAMPLES PER CAVITY ACCEPTANCE CRITERIA: ACCEPT = 0 / REJECT = 1. COLLAR CONCENTRICITY: SUPPORT RING CONCENTRIC WITHIN 2.0 MM TO THE COLLAR THROUGH THE CUT. FREQUENCY: HOURLY SAMPLE QUANTITY: 6 SAMPLES OF DISC COLLAR MACHINE ACCEPTANCE CRITERIA: ACCEPT = 0 / REJECT = 1. ADHESIVE DISC ALIGNMENT: THE DISC MUST NOT CONTACT THE SRP ADHESIVE DISC ID COLLAR AND MUST BE CONCENTRIC WITHIN 2.0MM. FREQUENCY: HOURLY SAMPLE QUANTITY: 3 SAMPLES PER CAVITY ACCEPTANCE CRITERIA: ACCEPT = 0 / REJECT = 1. DEFECT RATE ANALYSIS: THERE HAVE BEEN ONLY 10 DEFECTIVE PART 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 LEAKAGE WHICH SHOULD BE 0.25% BASED ON OUR STANDARD OPERATING PROCEDURE (SOP). IN ADDITION, ALL 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. IMPORTANTLY TO DATE, IT IS WELL WITHIN OUR ACCEPTED ACCEPTABLE QUALITY LEVEL (AQL) LEVEL FOR THIS TYPE OF FAILURE MODE OR DEFECT. CONCLUSIONS: 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. 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

    THE END USER CALLED TO REPORT THAT THE STARTER HOLE OF TEN SKIN BARRIER WAS OFF-CENTER. HE WAS UNABLE TO MOLD THE PRODUCT PROPERLY BECAUSE THERE WAS NOT ENOUGH MATERIAL ON ONE SIDE. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242598 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 411802 3J03051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown