BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL FOAM

    MDR report key: 15585667 · Received October 12, 2022

    Report

    Report Number
    1000317571-2022-00328
    Event Type
    Malfunction
    Date Received
    October 12, 2022
    Report Date
    September 19, 2022
    Manufacturer
    CONVATEC LTD
    Product Code
    NAC
    UDI-DI
    00768455123841
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NAME OF RETAILER: MEDFIRST. COMPLAINANT STREET ADDRESS: (B)(6). COMPLAINANT CITY: (B)(6). COMPLAINANT STATE/PROVINCE: (B)(6). COMPLAINANT POSTAL CODE: (B)(6). COMPLAINANT PHONE NUMBER:(B)(6). COMPLAINANT COUNTRY: (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 (B)(4).

    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. A BATCH RECORD REVIEW WAS COMPLETED AND NO DISCREPANCIES WERE FOUND. ALL IN-PROCESS STAT SAMPLE QUALITY CHECKS WERE SATISFACTORY. AQUACEL FOAM N/ADH 15X15(1X5) NAI WAS MANUFACTURED UNDER SYSTEM APPLICATION PRODUCT (SAP) CODE 1703996 AND MANUFACTURING LOT NUMBER 1C00248 ON 03 MARCH 2021. LOT # 1C00248 WAS STERILISED UNDER ORDER IDENTIFICATION 2841865 AND RELEASED ON REVIEW OF RESULTS OF STERILISATION PROVIDED BY STERILISATION COMPANY STERIGENICS. ALL OF THE RESULTS WERE WITHIN SPECIFICATION AND PRODUCTS WERE RELEASED. NO NONCONFORMITY WAS IDENTIFIED DURING THE MANUFACTURING PROCESS OF LOT 1C00248. THIS IS THE ONLY COMPLAINT FOR THE AFFECTED LOT REGISTERED WITHIN DATABASE. 3 PHOTOGRAPHS WERE RECEIVED FOR THIS ISSUE AND HAS BEEN EVALUATED IN ACCORDANCE WITH WORK INSTRUCTION (WI). THE PHOTOGRAPH CONFIRMED THE EXPECTED PRODUCT AND THE COMPLAINT ISSUE WHERE FOREIGN MATTER (HAIR) CAN BE SEEN ON WITHIN THE PRIMARY PACK. A NONCONFORMITY(NC) WAS OPENED FOR THIS ISSUE FOR FOREIGN MATTER ON THE DRESSING. AN INVESTIGATION WAS RAISED AND IDENTIFIED THAT THE ROOT CAUSE WAS PERSONNEL, AS THE FOREIGN MATTER WAS A HUMAN HAIR. A CORRECTIVE/PREVENTATIVE ACTION (CAPA) WAS RAISED TO COVER CORRECTIVE AND PREVENTATIVE ACTIONS FOR RETRAINING OF PERSONNEL IN MANUFACTURING FOR GOOD MANUFACTURING PRACTICE (GMP), AWARENESS TRAINING FOR BULK PACKING AND MICROBIOLOGY TRAINING FOR MANUFACTURING SHIFTS. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, STANDARD OPERATING PROCEDURE (SOP). FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE: 1000317571.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HAIRS WERE FOUND INSIDE THE PRIMARY PACKAGING. THE PRODUCT WAS NOT USED BY PATIENT. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    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
    2895131 AQUACEL FOAM DRESSING,WOUND,HYDROPHILIC NAC CONVATEC LTD 420635 1C00248 00768455123841

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown