BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 25122109 · Received May 8, 2026

    Report

    Report Number
    9618003-2026-00916
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Report Date
    April 20, 2026
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    UDI-DI
    00768455187027
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE 9 OF 10 BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. BATCH RECORD REVISION RESULTS: LOT 6A03813 WAS MANUFACTURED ON 15/JAN/2026, IN ATS 2 LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINT ENGINEER I PERFORMED A BATCH RECORD REVIEW ON 29/APR/2026, 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. 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 29/APR/2026, COMPLAINTS ENGINEER I RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE 6A03813 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 29/APR/2026, COMPLAINTS ENGINEER I RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) (S) ASSOCIATED TO THE MALFUNCTION ¿SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G MISALIGNMENT OR OFF CENTER), DEFECT FOR THE LOT NUMBER 6A03813 AND AS RESULT, NO NONCONFORMANCE / 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: TEST METHODS (TM) ¿PACKAGE SEAL INTEGRITY NONCONFORMITIES - METHOD 8¿ FREQUENCY: HOURLY SAMPLE QUANTITY: 1 MARKET UNIT ACCEPTANCE CRITERIA: ACCEPT = 0 / REJECT = 1. 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. CONCENTRICITY METER: (45MM FLANGE: 3DKA0001-01) 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 PARTS CONFIRMED TO DATE FROM A LOT SIZE OF (B)(4) PRODUCTS. THIS REPRESENTS A DEFECT RATE OF ONLY (B)(4) PERCENT WHICH IS WELL WITHIN AN APPROPRIATE ACCEPTABLE QUALITY LEVEL (AQL) FOR LEAKAGE WHICH SHOULD BE 0.25 PERCENT 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 CUSTOMER REPORTED THAT TEN WAFERS (MOLDABLE) FROM TWO MARKET UNIT BOXES WITH SAME LOT NUMBER HAD OFF-CENTERED STARTER HOLE PRIOR TO USE, MAKING THE PRODUCT UNUSABLE. THE CUSTOMER WAS A LONG-TIME USER OF THE PRODUCT, USUALLY HAD A WEAR TIME OF THREE DAYS. THERE WAS A HISTORY OF MULTIPLE COMPLAINTS RELATED TO THE SAME ISSUE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392651 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 411802 6A03813 00768455187027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown