BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL FOAM

    MDR report key: 17349785 · Received July 19, 2023

    Report

    Report Number
    1000317571-2023-00171
    Event Type
    Malfunction
    Date Received
    July 19, 2023
    Date of Event
    June 15, 2023
    Report Date
    June 19, 2023
    Manufacturer
    CONVATEC LTD
    Product Code
    NAC
    UDI-DI
    00768455157310
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: D9: DEVICE AVAILABLE FOR EVALUATION HAS BEEN SELECTED AS YES & DATE RETURNED TO MFG WAS ADDED AS WELL. 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. AQ FOAM PRO HEEL19.8X14CM 1X10 STER EUR WAS MANUFACTURED UNDER SAP CODE 1727476 AND MANUFACTURING LOT NUMBER 2J02037 ON 24 SEPTEMBER 2022. LOT # 2J02037 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 2J02037. THERE ARE 10 COMPLAINTS FOR THIS AFFECTED LOT NUMBER IN DATABASE. THIS COMPLAINT IS FOR AN ABSORPTION ISSUE WITH A SINGLE PATIENT. THIS BATCH WAS CONSIDERED TO BE A HOT BATCH. ONE PHOTOGRAPH WAS RECEIVED FOR THIS ISSUE AND HAS BEEN EVALUATED IN ACCORDANCE WITH WORK INSTRUCTIONS. THE PHOTOGRAPH DOES NOT DISPLAY THE LOT NUMBER AND PRODUCT, AS IT SHOWS THE USED DRESSING. THE USED DRESSING SHOWS BLOOD SPOTS ON THE DRESSING PAD, AS WELL AS EXTENDED ONTO THE ADHESIVE BORDER. THE ADHESIVE BORDER IS FOLDED OVER ONTO THE DRESSING PAD IN PARTS. THE PHOTO ALSO SHOWS AN UNKNOWN MATERIAL IN THE BOTTOM RIGHT OF THE IMAGE BENEATH THE DRESSING WHICH MAY BE A PRIMARY DRESSING USED TO PACK A CAVITY WOUND. 5 DRESSINGS FOR THE AFFECTED BATCH WERE RETURNED BY THE COMPLAINANT AND RECEIVED AT DEESIDE MANUFACTURING PLANT ON 15TH AUGUST 2023. ALL 5 DRESSINGS WERE FORM A SINGLE SECONDARY CARTON AND WERE UNUSED. NO NON-CONFORMANCE/ CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) WAS OPENED FOR THIS ISSUE, AS NO EVIDENCE COULD BE FOUND TO CONFIRM THE ABSORPTION ISSUE UNDER COMPLAINT. THE AQUACEL HYDROFIBRE REELSTOCK USED WITHIN THIS BATCH WAS TESTED FOR ABSORPTION AND WAS CONFIRMED ALL 32 SAMPLES TAKEN FROM THE REELSTOCK WERE WITHIN SPECIFICATION. FOLLOWING THE RECEIPT OF THE DRESSINGS UNDER COMPLAINT, THE FINAL DRESSINGS WERE ALSO TESTED FOR ABSORPTION/FLUID UPTAKE. THE LABORATORY TESTING CONFIRMED THAT THE DRESSINGS HAD MET THE SPECIFICATION ABSORBENCY AND FLUID UPTAKE AS PER THE PRODUCT SPECIFICATION. AS SPECIFICATION OF FINAL AND INTERMEDIATE PRODUCTS WERE MET, THE COMPLAINT COULD NOT BE SUBSTANTIATED. IT IS NOT KNOWN IF THE CUSTOMER HAS BEEN RECEIVING ANY OTHER TREATMENT WHICH MAY PREVENT THE DRESSING FROM ABSORBING, FOR EXAMPLE COMPRESSION THERAPY, AS THIS CAN REDUCE THE ABSORBENCY OF FOAM PRODUCTS AS THE DRESSING IS NOT ALLOWED TO ¿BREATHE¿ AND RELEASE VAPOURS. THE BATCH WAS CONFIRMED AS THE UNDER COMPLAINT FROM 3 SEPARATE CUSTOMERS AT 2 DIFFERENT FACILITIES, BUT ALL CURRENT EVIDENCE CONFIRMS THE PRODUCT MET SPECIFICATION. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. 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

    MDR 1000317571-2023-00171 / DEVICE 2 OF 3. (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: (B)(4). MANUFACTURING SITE: (B)(4).

    Description of Event or Problem · 0

    TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H10 (ADDL MFG NARRATIVE).

    Description of Event or Problem · 0

    IT WAS REPORTED BY HEALTHCARE PROFESSIONAL CLINICAL NURSE SPECIALIST THAT THE DRESSING HAD AN ABSORBANCE ISSUE AND EVENT WAS IDENTIFIED ON (B)(6) 2023. ITS EVALUATION HAS BEEN RUNNING IN MANY HEALTHCARE CARE PROVIDER FACILITIES AND HAVE RECEIVED NEGATIVE FEEDBACK. THE PRODUCT WAS USED ON PATIENT, HOWEVER, THERE WAS NO HARM REPORTED FOR MALABSORPTION. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837359 AQUACEL FOAM DRESSING, WOUND, HYDROPHILIC NAC CONVATEC LTD 422356 2J02037 00768455157310

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown