BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL EXTRA

    MDR report key: 24636424 · Received March 19, 2026

    Report

    Report Number
    1000317571-2026-00045
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Report Date
    February 23, 2026
    Manufacturer
    CONVATEC LTD
    Product Code
    NAC
    UDI-DI
    00768455125630
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6 - INVESTIGATION RESULTS UNDER IMDRF CAUSE INVESTIGATION CODE, IMDRF INVESTIGATION FINDINGS, IMDRF CAUSE CONCLUSIONS, H11: INVESTIGATION SUMMARY. COMPLAINT: PRIMARY PACK TEARS, RIPS OR SHEDS MATERIAL DURING OPENING (STERILE PRODUCTS), REGION: SWEDEN, PRODUCT / SYSTEM APPLICATION PRODUCT (SAP): 1704596 AQUACEL EXTRA 15X15CM (1X5PK STER EUR), LOT: 5K03394, DATE OF MANUFACTURE: 14OCT2025, COMPLAINT REFERENCE: RECORD IN DATABASE, BATCH SIZE: (B)(4). RECORD IN DATABASE WAS RECEIVED FROM SWEDEN REPORTING; IT IS NOT OPENING AT THE SEAL, BUT TEARS OP AT THE SIDE INSTEAD, WHICH CONTAMINATES THE DRESSING AND MEANS IT HAS TO BE DISCARDED. FOR MATERIAL: 1704596 BATCH 5K03394. THE LOT WAS MANUFACTURED ON 14OCT2025 (B)(4). ONE PHOTOGRAPH WAS PROVIDED BY THE COMPLAINANT TO DEMONSTRATE THE REPORTED DEFECTIVE PRIMARY PACK. NO PHYSICAL SAMPLES WERE RETURNED TO CONVATEC FOR EVALUATION. THE ASSESSMENT WAS THEREFORE BASED SOLELY ON THE LIMITED PHOTOGRAPHIC EVIDENCE AVAILABLE. A FULL BATCH RECORD REVIEW WAS COMPLETED FOR LOT 5K03394 ALL QUALITY CONTROL (QC) INSPECTIONS AND FINAL RELEASE ACTIVITIES WERE RECORDED AS ACCEPTABLE. NO MATERIAL-RELATED OR CONTAMINATION-RELATED ISSUES WERE DOCUMENTED. GOOD MANUFACTURING PRACTICE (GMP) COMPLIANCE RECORDS CONFIRM APPROPRIATE GOWNING, ENVIRONMENTAL MONITORING, AND ADHERENCE TO DEFINED PROCEDURES DURING THE PRODUCTION PERIOD. NO CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) OR NONCONFORMANCES WERE RAISED IN RELATION TO THE PRODUCTION FOR ORDER 1864529. NO PROCESS DEVIATIONS OR CONTAMINATION-RELATED NONCONFORMANCES WERE IDENTIFIED FOR LOT 5K03394. NO TWO COMPLAINTS HAVE BEEN ASSIGNED TO BATCH 5K03394 ¿ 12 MONTH LOOKBACK. RECORD IN DATABASE: ORIGINATION FROM SWEDEN FOR PRIMARY PACKAGING TEARING WHEN OPENED. MALFUNCTION IMPACTING 1 DRESSING. RECORD IN DATABASE: ORIGINATION FROM NORWAY FOR ¿THE GASKET TEARS IN THE MIDDLE WHEN YOU OPEN THE GASKET, AND YOU CANNOT REMOVE THE PRODUCT STERILELY¿ MALFUNCTION: IMPACTING 1 DRESSING. A BROADER MATERIAL-LEVEL REVIEW FOR MATERIAL 1704596 (AQUACEL EXTRA 15X15CM (1X5PK STER EUR)) IDENTIFIED ONE FURTHER COMPLAINT WITH THE SAME MALFUNCTION OVER THE PAST 24MONTHS. MALFUNCTION: DATABASE: ORIGINATION FROM NORWAY FOR BATCH 5J03762 STATING ¿THE GASKET TEARS IN THE MIDDLE WHEN YOU OPEN THE GASKET, AND YOU CANNOT REMOVE THE PRODUCT STERILELY. ¿IMPACTING 3 DRESSINGS. THESE ARE ALL LINKED TO HEAVY SEALS IN ON THE SINE WAVE OF THE PRIMARY PACK. ALL COMPLAINTS ORIGINATE FROM EUROPEAN AREA (SWEDEN AND NORWAY). THE AVAILABLE EVIDENCE INDICATES A LOW-FREQUENCY RECURRING DEFECT ACROSS MULTIPLE BATCHES RATHER THAN A SINGLE BATCH-SPECIFIC OCCURRENCE. THE CURRENT COMPLAINT RELATES TO ONE PRIMARY PACK REPORTED WITH TEARING WHEN OPENING. (B)(4). GIVEN THE LOW OCCURRENCE RATE (B)(4), THE COMPLAINT FREQUENCY REMAINS LOW RELATIVE TO THE TOTAL DISTRIBUTED QUANTITY. THE AVAILABLE EVIDENCE INDICATES A LOW-FREQUENCY RECURRING DEFECT ACROSS MULTIPLE BATCHES RATHER THAN A SINGLE BATCH-SPECIFIC OCCURRENCE. 2 ADDITIONAL SIMILAR COMPLAINTS HAVE BEEN IDENTIFIED ACROSS DISTRIBUTED UNITS OF BATCH 5K03394. BASED ON THE COMBINED DATA SET, THE RISK TO PRODUCT QUALITY AND PATIENT SAFETY REMAINS MINIMAL. ACROSS THE FULL MANUFACTURED POPULATION OF (B)(4): ONLY 2 ADDITIONAL PACK TEAR-RELATED COMPLAINT HAS BEEN RECEIVED. BATCH RECORD REVIEW, IN-PROCESS INSPECTIONS, AND DEVICE HISTORY CHECKS IDENTIFIED NO DEVIATIONS, NO RECURRING ISSUES, AND NO PROCESS-RELATED TRENDS. THE OBSERVED DEFECT RATE (B)(4) REMAINS BELOW THE NOTIONAL (B)(4) ACCEPTABLE QUALITY LEVEL (AQL) LIMIT, CONFIRMING NO EVIDENCE OF AN ACCEPTABLE QUALITY LEVEL (AQL) EXCURSION. MULTIPLE COMPLAINTS HAVE BEEN IDENTIFIED FOR MATERIAL 1704596 (AQUACEL EXTRA 15X15CM (1X5PK STER EUR)) WITH MALFUNCTION (PRIMARY PACK TEARS, RIPS OR SHEDS MATERIAL DURING OPENING) ACROSS MORE THAN ONE BATCH (5K03394 AND 5J03762). THESE EVENTS, REPORTED FROM MULTIPLE REGIONS (SWEDEN AND NORWAY), DEMONSTRATE A CONSISTENT FAILURE MODE ASSOCIATED WITH TEARING OF THE PRIMARY PACK DURING OPENING, INDICATING A RECURRING ISSUE BEYOND A SINGLE BATCH. ALTHOUGH THE OVERALL DEFECT RATE REMAINS LOW RELATIVE TO THE TOTAL DISTRIBUTED QUANTITIES, THE RECURRENCE OF SIMILAR COMPLAINTS ACROSS MULTIPLE BATCHES INDICATES A POTENTIAL WEAKNESS IN THE SEALING PROCESS OR MATERIAL PERFORMANCE, PARTICULARLY ASSOCIATED WITH THE SINE WAVE SEAL AREA. IN ACCORDANCE WITH WORK INSTRUCTIONS (WI), A CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) IS REQUIRED WHERE THERE WAS EVIDENCE OF: RECURRING DEFECT SIGNATURES ACROSS BATCHES. POTENTIAL PROCESS OR MATERIAL-RELATED VARIATION. NEED FOR EVALUATION OF EXISTING CONTROLS. THEREFORE, A CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) DATABASE WILL BE RAISED TO: INVESTIGATE SEALING PROCESS PARAMETERS (TEMPERATURE, PRESSURE, DWELL TIME) ACROSS AFFECTED BATCHES: ASSESS MATERIAL CONSISTENCY AND SEAL INTEGRITY PERFORMANCE. REVIEW EQUIPMENT SETTINGS AND VARIABILITY (E.G. PMK LINE PERFORMANCE). EVALUATE INSPECTION AND RELEASE CONTROLS FOR DETECTION CAPABILITY. IMPLEMENT CORRECTIVE AND PREVENTIVE ACTIONS TO REDUCE RECURRENCE. AT THIS STAGE, THE ISSUE IS CONSIDERED A LOW-FREQUENCY BUT RECURRING DEFECT ACROSS BATCHES, WITH NO EVIDENCE OF WIDESPREAD SYSTEMIC FAILURE, BUT REQUIRING FURTHER INVESTIGATION TO CONFIRM THE EXTENT AND ROOT CAUSE. THE BATCH REMAINS WITHIN SPECIFICATION AND ACCEPTABLE QUALITY LIMITS. THE ISSUE IS CONSIDERED ISOLATED, WITH NO SYSTEMIC RECURRENCE IDENTIFIED. CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) RAISED TO DETERMINE THE ROOT CAUSE. THE COMPLAINT WILL BE MONITORED THROUGH ROUTINE TRENDING AND 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: 1000317571.

    Additional Manufacturer Narrative · 0

    E1: COMPLAINANT CITY: (B)(6). COMPLAINANT COUNTRY: SWEDEN. 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: 1000317571.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    THE NURSE PRACTITIONER REPORTED THAT THE PACKAGE DID NOT OPEN AT THE INTENDED SEAL AND INSTEAD TORE FROM THE SIDE, WHICH RESULTED IN CONTAMINATION OF THE DRESSING AND REQUIRED IT TO BE DISCARDED. NO UNUSED SAMPLES ARE AVAILABLE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150066 AQUACEL EXTRA DRESSING, WOUND, HYDROPHILIC NAC CONVATEC LTD 420673 5K03394 00768455125630

    Patients

    Seq Age Sex Outcome Treatment
    1