BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM

    MDR report key: 23629026 · Received November 24, 2025

    Report

    Report Number
    9618003-2025-02950
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Report Date
    November 6, 2025
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    NAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE 1 OF 5. E1: COMPLAINANT STATE: (B)(6). COMPLAINANT COUNTRY: JAPAN. NAME OF AFFILIATION: (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. BATCH RECORD REVIEW: LOT: 4G03499 WAS MANUFACTURED 17/JUL/2024, IN DOYEN B LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINTS ENGINEER PERFORMED A BATCH RECORD REVIEW ON 13/NOV/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): 1000854 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 REPORTED MALFUNCTION COULD BE GENERATED DURING THE MANUFACTURING PROCESS OF THE FINAL LINE, THEREFORE NO FURTHER BATCH RECORD REVIEW OF THE SUBASSEMBLY LOTS WAS REQUIRED. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: NO PHOTOGRAPHS ASSOCIATED WITH THIS CASE WERE RECEIVED AND NO UNUSED RETURN SAMPLE WAS EXPECTED. HISTORICAL COMPLAINTS REVIEW: ON 13/NOV/2025, COMPLAINTS ENGINEER RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE 4G03499 LOT FOR THE MALFUNCTION ¿PRIMARY PACK (STERILE PRODUCTS) EXHIBITS EXTERNAL CONTAMINATION (E.G. WATER MARKS, STAINS).¿ DEFECT AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED. HISTORICAL NONCONFORMANCE REVIEW: ON 13/NOV/2025, COMPLAINTS ENGINEER RAN A QUERY IN DATABASE LOOKING FOR ANY IN-PROCESS NON-CONFORMANCE (NC)'S / CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) (S) ASSOCIATED TO THE MALFUNCTION ¿PRIMARY PACK (STERILE PRODUCTS) EXHIBITS EXTERNAL CONTAMINATION (E.G. WATER MARKS, STAINS).¿ DEFECT FOR THE LOT NUMBER: 4G03499 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 WERE PERFORMED IN THE MANUFACTURING LINES, IN ORDER TO IDENTIFY THIS FAILURE MODE IN OUR MANUFACTURING PROCESS: TEST METHODS (TM) "STERILE PACKAGING INSPECTION FOR NONCONFORMITIES - VISUAL ATTRIBUTES": FREQUENCY FIRST UNITS AND: EVERY 30 MINUTES. SAMPLE QUANTITY: 1 MARKET UNIT O NOT LESS THAN 5 CHEVRONS. ACCEPTANCE CRITERIA: ACCEPT = 0/ REJECT = 1. DEFECT RATE ANALYSIS: THERE HAVE ONLY BEEN 5 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 0.25% BASED ON OUR DR-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 0.25. TO DATE, IT IS WELL WITHIN OUR ACCEPTED ACCEPTABLE QUALITY LEVEL (AQL) LEVEL FOR THIS TYPE OF FAILURE MODE OR DEFECT. CONCLUSION: NO PHOTOGRAPHS FOR THIS COMPLAINT ISSUE. THEREFORE, IT WAS NOT POSSIBLE TO CONDUCT AN INVESTIGATION FOR THE REPORTED ISSUE. 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 DISTRIBUTOR COMPLAINED REGARDING THE BLACK STAINS ALONG THE EDGE OF THE PRIMARY PACKAGE OF THE DRESSING. THE PRODUCT WAS NOT USED. NO PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2556020 DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 187660 4G03499

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown