BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3W0650 - AQUACEL FOAM

    MDR report key: 15011430 · Received July 14, 2022

    Report

    Report Number
    1000317571-2022-00096
    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

    ROLE OF COMPLAINANT : REGIONAL CLINICAL SPECIALIST . NAME OF HOSPITAL : (B)(6) HEALTH. 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: (B)(4). MANUFACTURING SITE: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: D9: DEVICE AVAILABLE FOR EVAL & DATE RETURNED TO MFG. H3: DEVICE EVALUATED BY MFG. H6 - INVESTIGATION RESULTS UNDER IMDRF CAUSE INVESTIGATION CODE, IMDRF INVESTIGATION FINDINGS, IMDRF CAUSE CONCLUSIONS. H10: INVESTIGATION SUMMARY. 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 OCTOBER 2021. LOT # 1K01013 WAS STERILISED UNDER REFERENCE (B)(4) 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 1K01013. THERE ARE 2 COMPLAINTS FOR THIS AFFECTED LOT NUMBER IN DATABASE- THIS COMPLAINT FOR DRESSING LEAVING RESIDUE IN THE WOUND AND THE ADDITIONAL COMPLAINT NOTED ABOVE FOR MACERATION. ONE PHOTOGRAPH WAS RECEIVED FOR THIS ISSUE AND HAS BEEN EVALUATED IN ACCORDANCE WITH WORK INSTRUCTION (WI). 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 BOTH COMPLAINTS, RECEIVED ON 29TH JUNE 2022. A NON-CONFORMANCE WAS RAISED FOR THIS COMPLAINT, ALSO INCLUDING COVERING THE ASSOCIATED COMPLAINTS, AS NOTED ABOVE. THE RESEARCH AND DEVELOPMENT TEAM WERE ABLE TO COMMENT ON THE COMPLAINTS, STATING THAT THE RESIDUE UNDER COMPLAINT WILL BE COMMON SILICONE GEL. SILICONE GELS HAVE A FINE BALANCE WHEN CURING FOR ADHESION; A SOFTER GEL WAS STICKIER BUT SOFTER SO CAN LEAVE RESIDUE, A HARDER GEL WAS LESS ADHESIVE TO THE SKIN BUT NO RISK OF RESIDUE. THE RESIDUE IS COMMON WITH SILICONES AND IS REMOVED EASILY. ADDITIONALLY, IT WOULD NOT LEAVE SILICONE IN THE WOUND AS SILICONE IS HYDROPHOBIC AND HENCE WILL NOT STICK TO THE WOUND, ONLY TO THE DRY PERI-WOUND SKIN. THE SILICONE IS HIGHLY BIOCOMPATIBLE, AS DOCUMENTED IN THE BIOMEDICAL AND ENVIRONMENTAL RESEARCH, SO THERE WOULD BE NO RISK TO PATIENT, EVEN IF SOME RESIDUE DID GET LEFT. THESE SILICONES ARE USED IN IMPLANTS, SO ARE SAFE AND BIOCOMPATIBLE. AS THE SILICONE ADHESIVE IS APPLIED AND CURED AT A SUPPLIER SITE, THE SUPPLIER HAS BEEN CONTACTED REGARDING THESE COMPLAINTS. HOWEVER, NO DISCREPANCIES WERE IDENTIFIED IN THE SUPPLIERS DOCUMENTATION, AND THE AFFECTED LOT WAS CONFIRMED AS BEING WITHIN SPECIFICATION WITH NO UNUSUAL EVENTS RECORD ON THE BATCH RECORDS. 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 HAD LEFT SILICONE RESIDUE ON THE SKIN, AND THUS SHE BELIEVED IT WAS LEAVING RESIDUE IN THE WOUNDS AS WELL. THIS WAS MEANT TO BE USED AS MORE OF A PROTECTIVE DRESSING. 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
    2060867 L3W0650 - AQUACEL FOAM DRESSING, WOUND, DRUG NAC CONVATEC LTD 421580 1K01013 00768455140503

    Patients

    Seq Age Sex Outcome Treatment
    1 Male