BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3W0650 - AQUACEL FOAM

    MDR report key: 15011381 · Received July 14, 2022

    Report

    Report Number
    1000317571-2022-00110
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Report Date
    June 15, 2022
    Manufacturer
    CONVATEC LTD
    Product Code
    NAC
    UDI-DI
    00768455140503
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE 2 OF 5. (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. (B)(4).

    Additional Manufacturer Narrative · 0

    A BATCH RECORD REVIEW WAS COMPLETED, AND NO DISCREPANCIES WERE FOUND. AQUACEL FOAM PRO SACRAL 24X21.5CM 1X5 NAI WAS MANUFACTURED UNDER SYSTEM APPLICATION PRODUCT (SAP) CODE 1714053 AND MANUFACTURING LOT NUMBER 1K01013 ON 11/10/2021. LOT # 1K01013 WAS STERILIZED UNDER REFERENCE (B)(4) AND RELEASED ON REVIEW OF RESULTS OF STERILIZATION PROVIDED BY STERILIZATION COMPANY STERIGENICS. ALL OF THE RESULTS WERE WITHIN SPECIFICATION AND PRODUCTS WERE RELEASED. NO NONCONFORMITY WAS IDENTIFIED DURING THE MANUFACTURING PROCESS OF LOT 1K01013. THERE ARE 2 COMPLAINTS FOR THIS AFFECTED LOT NUMBER IN DATABASE - THIS COMPLAINT FOR MACERATION AND THE ADDITIONAL COMPLAINT NOTED ABOVE FOR THE DRESSING LEAVING RESIDUE IN THE WOUND. ONE PHOTOGRAPH WAS RECEIVED FOR THIS ISSUE AND HAS BEEN EVALUATED IN ACCORDANCE WITH WORK INSTRUCTION. THE PHOTOGRAPH CONFIRMS THE EXPECTED LOT NUMBER AND PRODUCT BUT DOES NOT SHOW THE COMPLAINT ISSUE. THE SAMPLES UNDER COMPLAINT WERE REQUESTED FOR INVESTIGATION AS PART OF COMPLAINT RECORDS, RECEIVED ON 29/06/2022. A NON-CONFORMANCE WAS OPEN FOR THIS COMPLAINT RAISED AS A RESULT OF THE RELATED COMPLAINTS RELATING TO SILICONE RESIDUE. THE ORIGINAL COMPLAINT STATES THAT THE DRESSINGS WERE BEING TRAILED AS A POTENTIAL REPLACEMENT FOR ¿MEPILEX¿ (COMPETITOR¿S FOAM DRESSINGS), AND THAT THE NURSE FELT THE DRESSINGS WERE NOT ABSORPTIVE AS THE COMPETITOR¿S PRODUCT AND THAT THE WOUND WAS LEFT WITH AREAS OF MACERATION. THE SAMPLE DRESSINGS RECEIVED WERE TESTED FOR FLUID UPTAKE AS PER PRODUCT SPECIFICATION FOR AQUACEL FOAM PRO DRESSINGS. THE FLUID UPTAKE RESULTS FOR THE DRESSING FROM LOT 1K01013 WAS FOUND TO BE WITHIN SPECIFICATION, SO THE MACERATION NOTED BY THE COMPLAINANT MAY INDICATE THAT THE DRESSING SIZE WAS NOT SUITABLE FOR THE EXUDATE LEVELS RELEASED BY THE WOUND. 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: 1000317571.

    Description of Event or Problem · 0

    IT WAS REPORTED BY COMPANY REPRESENTATIVE THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT FIVE DRESSINGS FROM ONE MARKET UNIT WERE NOT AS ABSORPTIVE AS THE OTHER COMPANY'S DRESSING AND LEFT THE WOUND WITH AREAS OF MACERATION. THEY HAD BEEN TRIALING THE PRODUCT AS A REPLACEMENT FOR OTHER COMPANY¿S FOAM DRESSING. THREE ATTEMPTS HAVE BEEN MADE AND ONE ELECTRONIC MAIL (EMAIL) WAS SENT REQUESTING FURTHER INFORMATION TO CONTACT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE BUT IT WAS NOT POSSIBLE TO CONTACT HER. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. A PHOTOGRAPH DEPICTING THE ISSUE WAS 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
    2348788 L3W0650 - AQUACEL FOAM DRESSING, WOUND, DRUG NAC CONVATEC LTD 421580 1K01013 00768455140503

    Patients

    Seq Age Sex Outcome Treatment
    1 Male