BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL EXTRA

    MDR report key: 24636422 · Received March 19, 2026

    Report

    Report Number
    1000317571-2026-00046
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    February 6, 2026
    Report Date
    February 25, 2026
    Manufacturer
    CONVATEC LTD
    Product Code
    NAC
    UDI-DI
    00768455125630
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: COMPLAINANT CITY: (B)(6). COMPLAINANT STATE: (B)(6). COMPLAINANT COUNTRY: SWEDEN NAME OF AFFILIATION: (B)(6). 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.

    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. 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; ¿THE PACKAGING CANNOT BE OPENED WITHOUT TEARING IT APART, THEREBY COMPROMISING STERILITY. 1 PRODUCT OUT OF A BOX OF 10 WAS IMPACTED.¿ NO HARM TO PATIENT OR DAMAGE TO PROPERTY WAS ALLEGED. FOR MATERIAL 1704596 BATCH 5K03394, THE LOT WAS MANUFACTURED ON 14OCT2025. (B)(4). NO PHOTOGRAPHS WERE PROVIDED BY THE COMPLAINANT TO DEMONSTRATE THE REPORTED DEFECT. NO PHYSICAL SAMPLES WERE RETURNED TO CONVATEC FOR EVALUATION. THEREFORE, THE COMPLAINT CANNOT BE CONFIRMED, AND THE INVESTIGATION IS LIMITED TO RECORD REVIEW AND TREND ANALYSIS. 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 PACKAGING-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 PRODUCTION ORDER (B)(4). NO PROCESS DEVIATIONS OR PACKAGING-RELATED NONCONFORMANCES WERE IDENTIFIED FOR LOT 5K03394. TWO ADDITIONAL COMPLAINTS HAVE BEEN ASSIGNED TO BATCH 5K03394 DURING THE 12-MONTH LOOKBACK: RECORD IN DATABASE (SWEDEN): PRIMARY PACKAGING TEARING WHEN OPENED ¿ (B)(4). RECORD IN DATABASE (NORWAY): ¿THE GASKET TEARS IN THE MIDDLE WHEN OPENED, PREVENTING STERILE REMOVAL OF THE PRODUCT¿ ¿ (B)(4). A BROADER MATERIAL-LEVEL REVIEW FOR MATERIAL 1704596 (AQUACEL EXTRA 15X15CM (1X5PK STER EUR)) IDENTIFIED ONE FURTHER COMPLAINT WITH THE SAME MALFUNCTION CODE OVER THE PAST 24 MONTHS: RECORD IN DATABASE (NORWAY, BATCH 5J03762): ¿THE GASKET TEARS IN THE MIDDLE WHEN OPENED, PREVENTING STERILE REMOVAL OF THE PRODUCT¿ ¿ (B)(4). THESE COMPLAINTS ARE ASSOCIATED WITH TEAR BEHAVIOUR DURING OPENING OF THE PRIMARY PACK, POTENTIALLY LINKED TO SEAL CHARACTERISTICS (E.G. INCREASED SEAL STRENGTH OR LOCALISED VARIATION ALONG THE SINE WAVE SEAL). ALL COMPLAINTS ORIGINATE FROM THE EUROPEAN REGION (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 DURING OPENING. THE TOTAL BATCH SIZE WAS (B)(4). OF THESE, (B)(4) WERE DISTRIBUTED, WITH NO ADDITIONAL FEEDBACK OF SIMILAR ISSUES, AND (B)(4) REMAIN IN DISTRIBUTION CENTER (DC) INVENTORY WITHOUT REPORTED DEFECTS. (B)(4). A TOTAL OF THREE COMPLAINTS HAVE BEEN IDENTIFIED FOR THIS BATCH. BASED ON THE COMBINED DATA SET, THE RISK TO PRODUCT QUALITY AND PATIENT SAFETY REMAINS LOW, ALTHOUGH A RECURRING DEFECT MECHANISM IS INDICATED. ACROSS THE FULL MANUFACTURED POPULATION OF (B)(4): A TOTAL OF (B)(4) PACK TEAR-RELATED COMPLAINTS HAVE BEEN RECEIVED. BATCH RECORD REVIEW, IN-PROCESS INSPECTIONS, AND DEVICE HISTORY CHECKS IDENTIFIED NO DEVIATIONS, NO RECURRING ISSUES, AND NO PROCESS-RELATED TRENDS DURING MANUFACTURE. (B)(4). CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) JUSTIFICATION: 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 IS 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) IN 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 RECURRING DEFECT ACROSS BATCHES, WITH NO EVIDENCE OF WIDESPREAD SYSTEMIC FAILURE, BUT REQUIRING FURTHER INVESTIGATION TO DETERMINE THE EXTENT AND ROOT CAUSE. THE BATCH REMAINS WITHIN SPECIFICATION AND ACCEPTABLE QUALITY LIMITS. THE ISSUE IS NOT CONSIDERED ISOLATED, AND REFLECTS A RECURRING DEFECT ACROSS BATCHES REQUIRING CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) INVESTIGATION. CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) HAS BEEN RAISED TO DETERMINE THE ROOT CAUSE. THE COMPLAINT WILL CONTINUE TO BE MONITORED THROUGH ROUTINE TRENDING AND THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, STANDARD OPERATING PROCEDURE, 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.

    Description of Event or Problem · 0

    THE NURSE REPORTED THAT THE PACKAGING COULD NOT BE OPENED WITHOUT TEARING IT APART, WHICH COMPROMISED STERILITY. THE PRODUCT WAS NOT USED. NO PHOTO WAS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150065 AQUACEL EXTRA DRESSING, WOUND, HYDROPHILIC NAC CONVATEC LTD 420673 5K03394 00768455125630

    Patients

    Seq Age Sex Outcome Treatment
    1