BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 24971952 · Received April 23, 2026

    Report

    Report Number
    9618003-2026-00736
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Report Date
    April 1, 2026
    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 1 OF 9 E1: EVENT COUNTRY: POLAND BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: NO PHOTOGRAPH ASSOCIATED WITH THIS CASE WAS RECEIVED. NO RETURN SAMPLE HAS BEEN RECEIVED FOR THIS COMPLAINT. BATCH RECORD REVISION RESULTS: PACKAGING PROCESS PERFORMED IN THE ATS #2 LINE: LOT 5G02122 WAS MANUFACTURED ON 09/JULY/2025, IN ATS MANUFACTURING LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 16/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) 1701062 AND MANUFACTURING ORDER 1822035. THE PRODUCTION PROCESS, IN-PROCESS CONTROL, TESTING RESULTS, AND PACKAGING OF PRODUCTS WERE RUN ACCORDING TO THE PROCESS INSTRUCTION (PI). TRILAMINATION PROCESS PERFORMED IN THE DELTA CRUSADER LINE: THE SUBASSEMBLY LOT: 5F04825, ORDER (B)(4), MATERIAL 1220484, WAS MANUFACTURED ON 07/09/2025 IN THE DELTA CRUSADER NEW MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. EXTRUSION, LAMINATION & CUTTING PROCESS PERFORMED IN THE EXTRUSION, LAMINATION & CUTTING PROCESS (ELC) LINE: THE SUBASSEMBLY LOT: 5F00549, ORDER (B)(4), MATERIAL 1220481, WAS MANUFACTURED ON 06/06/2025 IN THE ELC MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 5G01025, ORDER (B)(4), MATERIAL 1220481, WAS MANUFACTURED ON 07/04/2025 IN THE ELC MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 5E02750, ORDER (B)(4), MATERIAL 1220481, WAS MANUFACTURED ON 05/25/2025 IN THE ELC MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 5D00584, ORDER (B)(4), MATERIAL 1220481, WAS MANUFACTURED ON 04/02/2025 IN THE ELC MANUFACTURING LINE, WITH A TOTAL OF(B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 5C00230, ORDER (B)(4), MATERIAL 1220481, WAS MANUFACTURED ON 03/07/2025 IN THE ELC MANUFACTURING LINE, WITH A TOTAL OF 27,865 EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4M00989, ORDER (B)(4), MATERIAL 1220481, WAS MANUFACTURED ON 12/06/2024 IN THE ELC MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. MIXING PROCESS PERFORMED IN THE AMK MIXER LARGE, APV MIXER, AND AMK 450 MIXER 8 MANUFACTURING LINE: THE SUBASSEMBLY LOT: 5E01911, ORDER (B)(4), MATERIAL 1002206, WAS MANUFACTURED ON 05/09/2025 IN THE APV MIXER MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 5E06295, ORDER (B)(4), MATERIAL 1738336, WAS MANUFACTURED ON 05/30/2025 IN THE AMK MIXER LARGE MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 5C03008, ORDER (B)(4), MATERIAL 1738336, WAS MANUFACTURED ON 03/17/2025 IN THE AMK MIXER LARGE MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 5C06362, ORDER (B)(4), MATERIAL 1738336, WAS MANUFACTURED ON 04/01/2025 IN THE AMK MIXER LARGE MANUFACTURING LINE, WITH A TOTAL OF 11,511 EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 5E00399, ORDER (B)(4), MATERIAL 1738336, WAS MANUFACTURED ON 05/02/2025 IN THE AMK MIXER LARGE MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 5E06296, ORDER (B)(4), MATERIAL 1738336, WAS MANUFACTURED ON 05/31/2025 IN THE AMK MIXER LARGE MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 5G00355, ORDER (B)(4), MATERIAL 1002206, WAS MANUFACTURED ON 07/01/2025 IN THE APV MIXER MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 5F05912, ORDER (B)(4), MATERIAL 1738336, WAS MANUFACTURED ON 07/01/2025 IN THE AMK MIXER LARGE MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4H02537, ORDER (B)(4), MATERIAL 1002206, WAS MANUFACTURED ON 08/14/2024 IN THE AMK 450 MIXER 8 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 5D00686, ORDER (B)(4), MATERIAL 1002206, WAS MANUFACTURED ON 04/03/2025 IN THE APV MIXER MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 5E03021, ORDER (B)(4), MATERIAL 1738336, WAS MANUFACTURED ON 05/16/2025 IN THE AMK MIXER LARGE MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 5C01858, ORDER (B)(4), MATERIAL 1002206, WAS MANUFACTURED ON 03/12/2025 IN THE APV MIXER MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 5D00204, ORDER (B)(4), MATERIAL 1738335, WAS MANUFACTURED ON 04/02/2025 IN THE AMK MIXER LARGE MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 5C00228, ORDER (B)(4), MATERIAL 1738336, WAS MANUFACTURED ON 03/10/2025 IN THE AMK MIXER LARGE MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4M00597, ORDER (B)(4), MATERIAL 1002206, WAS MANUFACTURED ON 12/03/2024 IN THE AMK MIXER LARGE MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4H02064, ORDER (B)(4), MATERIAL 1738336, WAS MANUFACTURED ON 08/10/2024 IN THE MIXER 450 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4K01060, ORDER (B)(4), MATERIAL 1738336, WAS MANUFACTURED ON 10/08/2024 IN THE AMK 450 MIXER 8 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4L06110, ORDER (B)(4), MATERIAL 1738336, WAS MANUFACTURED ON 11/29/2024 IN THE AMK 450 MIXER 8 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4L05407, ORDER (B)(4), MATERIAL 1738336, WAS MANUFACTURED ON 12/06/2024 IN THE AMK MIXER LARGE MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 04/16/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. HISTORICAL COMPLAINTS REVIEW: ON 16/APR/2026, COMPLAINTS ENGINEER RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE 5G02122 LOT FOR THE MALFUNCTION ¿SKIN BARRIER DOES NOT MOLD AROUND STOMA (E.G TOO STIFF, TOO DRY, TEARS /CRUMBLES WHEN MOLDING) AT POINT OF APPLICATION.¿ DEFECT AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED. HISTORICAL NONCONFORMANCE REVIEW: ON 16/APR/2026, COMPLAINTS ENGINEER RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) (S) ASSOCIATED WITH THE MALFUNCTION ¿SKIN BARRIER DOES NOT MOLD AROUND STOMA (E.G TOO STIFF, TOO DRY, TEARS /CRUMBLES WHEN MOLDING) AT POINT OF APPLICATION.¿ DEFECT FOR THE FOLLOWING LOT NUMBERS G02122, 5F00549, 5G01025, 5E02750, 5D00584, 5C00230, 4M00989, 5E01911, 5E06295, 5C03008, 5C06362, 5E00399, 5G00355, 5F05912, 4H02537, 5D00686, 5E03021, 5C01858, 5D00204, 5C00228, 4M00597, 4H02064, 4K01060, 4L06110, 4L05407 AND AS A RESULT, NO NONCONFORMANCE / CAPA (S) FOR THIS MALFUNCTION WERE GENERATED DURING THE MANUFACTURING PROCESS OF THE REFERENCED LOTS. 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) " TENSILE TESTING": ¿ SAMPLE QUANTITY: (B)(4) ¿ ACCEPTANCE CRITERIA: ACCEPT = 0 / REJECT = 1 DEFECT RATE ANALYSIS: THERE HAVE BEEN (B)(4) DEFECTIVE PARTS CONFIRMED TO DATE FROM A LOT SIZE (B)(4) PRODUCTS. THIS REPRESENTS A DEFECT RATE OF 0.035 PERCENT, WHICH IS WELL WITHIN AN APPROPRIATE ACCEPTABLE QUALITY LEVEL (AQL) FOR THIS DEFECT WHICH SHOULD BE 0.65 PERCENT BASED ON OUR STANDARD OPERATING PROCEDURE (SOP). IN ADDITION, ALL OF THE IN-PROCESS TESTING ON THIS LOT DID NOT FIND A SINGLE DEFECTIVE POUCH, WHICH CONFIRMS THAT THE LOT IS UNLIKELY TO BREACH AN AQL OF 0.65. THIS ISSUE CERTAINLY APPEARS TO BE AN ISOLATED INCIDENT, BUT MORE IMPORTANTLY TO DATE, IT IS WELL WITHIN OUR ACCEPTED AQL LEVEL FOR THIS TYPE OF FAILURE MODE OR DEFECT. 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 NOTICED THAT THE MOLDED SKIN BARRIER WAS SPLITTING DURING MOLDING AND WAS NOT ADHERING. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569519 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 411811 5G02122

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown