BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM

    MDR report key: 23875880 · Received December 23, 2025

    Report

    Report Number
    9618003-2025-03380
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Report Date
    November 28, 2025
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    NAD
    UDI-DI
    00768455150939
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    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 4K07052 WAS MANUFACTURED 31/OCT/2024, IN DOYEN A LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). COMPLAINTS ENGINEER PERFORMED A BATCH RECORD REVIEW ON 29/DEC/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) 1704769 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 WAS FOUND WITHIN THE DOCUMENTATION. THE DEFECT REPORTED BY THE CUSTOMER COULD OCCUR DURING THE SUB-ASSEMBLY PROCESS PERFORMED IN THE EXTRUSION, LAMINATION & CUTTING PROCESS (ELC) MANUFACTURING LINE. FOR THIS REASON, A DETAILED BATCH RECORD REVIEW WAS PERFORMED OF THE SUBASSEMBLY LOT MANUFACTURED IN THIS LINE. THE SUBASSEMBLY LOT 4K06189, ORDER (B)(4), MATERIAL 1003412, WAS MANUFACTURED ON 29/OCT/2024 IN THE EXTRUSION, LAMINATION & CUTTING PROCESS (ELC) MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACHES. COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 29/DEC/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 4K07053, ORDER (B)(4), MATERIAL 1003412, WAS MANUFACTURED ON 02/NOV/2024 IN THE EXTRUSION, LAMINATION & CUTTING PROCESS (ELC) MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACHES. COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 29/DEC/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 4L00820, ORDER (B)(4), MATERIAL 1003412, WAS MANUFACTURED ON 09/NOV/2024 IN THE EXTRUSION, LAMINATION & CUTTING PROCESS (ELC) MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACHES. COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 29/DEC/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 29/DEC/2025, COMPLAINTS ENGINEER RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE 4K07052 LOT FOR THE MALFUNCTION ¿FOREIGN MATTER WITHIN PRODUCT, STERILE PRODUCTS (E.G. METAL CONTAMINATION IN DRESSINGS, PARTICULATES WITHIN FLUIDS, GELS ETC)¿ DEFECT AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED. HISTORICAL NONCONFORMANCE REVIEW: ON 29/DEC/2025, COMPLAINTS ENGINEER RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) (S) ASSOCIATED TO THE MALFUNCTION ¿FOREIGN MATTER WITHIN PRODUCT, STERILE PRODUCTS (E.G. METAL CONTAMINATION IN DRESSINGS, PARTICULATES WITHIN FLUIDS, GELS ETC)¿ DEFECT FOR THE LOT NUMBER 4K07052 AND AS RESULT, NO NONCONFORMANCE / CORRECTIVE AND 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) "VISUAL NONCONFORMITIES - LAMINATED ADHESIVE PRODUCTS": FREQUENCY: FIRST UNIT AND EVERY 30 MINUTES SAMPLE QUANTITY: 2 SAMPLES AT EACH PROCESS CONTROL POINT ACCEPTANCE CRITERIA: ACCEPT = 0/ REJECT = 1. DEFECT RATE ANALYSIS THERE HAVE BEEN 14 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 1.0% 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 1.0. TO DATE, IT IS WELL WITHIN OUR ACCEPTED ACCEPTABLE QUALITY LEVEL (AQL) LEVEL FOR THIS TYPE OF FAILURE MODE OR DEFECT. CONCLUSION: 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.

    Additional Manufacturer Narrative · 0

    DEVICE 1 OF 14 E1: COMPLAINANT STREET ADDRESS: (B)(6) COMPLAINANT COUNTRY: TAIWAN, PROVINCE OF 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 DISTRIBUTOR REPORTED THAT THE CUSTOMER REPORTED THE PRESENCE OF SPOTS WITH DIFFERENT COLOR FOUND DURING THE INBOUND INSPECTION OF THE FOURTEEN DRESSINGS. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1801641 DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 187957 4K07052 00768455150939

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown