BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM

    MDR report key: 24787953 · Received April 6, 2026

    Report

    Report Number
    9618003-2026-00658
    Event Type
    Malfunction
    Date Received
    April 6, 2026
    Report Date
    March 25, 2026
    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

    E1: COMPLAINANT STREET ADDRESS: (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. BATCH RECORD REVIEW: LOT: 4K07052 WAS MANUFACTURED 31/OCT/2024, IN DOYEN A LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINTS ENGINEER PERFORMED A BATCH RECORD REVIEW ON 30/MAR/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): 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 WERE 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) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 30/MAR/2026 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) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 30/MAR/2026 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) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 30/MAR/2026 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 WAS A PHOTOGRAPH ASSOCIATED WITH THIS CASE AND IN THIS, THE REPORTED DEFECT CAN BE SEEN. NO UNUSED RETURN SAMPLE WAS EXPECTED. HISTORICAL COMPLAINTS REVIEW: ON 30/MAR/2026, 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. AS A RESULT, ONE (1) ADDITIONAL COMPLAINT WAS IDENTIFIED; HOWEVER, IT WAS NOT ASSOCIATED WITH THE SAME FAILURE MODE AS THE COMPLAINT CURRENTLY UNDER INVESTIGATION. HISTORICAL NONCONFORMANCE REVIEW: ON 30/MAR/2026, 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 1 DEFECTIVE PART CONFIRMED TO DATE FROM A LOT SIZE OF (B)(4) PRODUCTS. THIS REPRESENTS A DEFECT RATE OF ONLY (B)(4), WHICH WAS WELL WITHIN AN APPROPRIATE ACCEPTABLE QUALITY LEVEL (AQL) 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 AQL OF 0.25. TO DATE, IT WAS WELL WITHIN OUR ACCEPTED AQL LEVEL FOR THIS TYPE OF FAILURE MODE OR DEFECT. PERSONNEL NOTIFICATION AND TRAINING: AS PART OF THE INVESTIGATION, THE TEAMS INVOLVED IN THE MANUFACTURING OF THE AFFECTED PRODUCT WERE INFORMED ABOUT THE REPORTED ISSUE. THE GOAL WAS TO RAISE AWARENESS AND REINFORCE THE IMPORTANCE OF INSPECTION PROTOCOLS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY DISTRIBUTOR THAT A CONTAMINANT HAIR WAS OBSERVED. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851775 DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 187957 4K07052 00768455150939

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown