BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL FOAM

    MDR report key: 8782071 · Received July 11, 2019

    Report

    Report Number
    1049092-2019-00204
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    June 24, 2019
    Manufacturer
    CONVATEC INC
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). A BATCH RECORD REVIEW INDICATES NO DISCREPANCIES. PM LOGS HAVE BEEN CHECKED AND NO DISCREPANCIES WERE FOUND. AMOUNT AFFECTED: 1PC. AQUACEL FOAM ADH 8X8CM WAS MANUFACTURED UNDER SAP CODE 1707743 AND MANUFACTURING LOT NUMBER 9B00938. LOT # 9B00938 WAS STERILIZED UNDER LOT 2153674 AND RELEASED ON REVIEW OF RESULTS PROVIDED BY STERILIZATION COMPANY STERIGENICS. ALL OF THE RESULTS WERE WITHIN SPECIFICATION AND THE PRODUCT WAS RELEASED. THE PRODUCTION PROCESS, IN-PROCESS TESTING AND PACKAGING OF PRODUCTS WAS RUN IN ACCORDANCE WITH PI12-150 VER. 16.0 AND PI12-151 VER. 26.0 FOR MACHINES DELTA AND CIRCLE RESPECTIVELY. VISUAL INSPECTION IN ACCORDANCE WITH TM-002 WAS COMPLETED AT THE BEGINNING OF THE ORDER AND EVERY 15 MINUTES FOLLOWING UNTIL THE ORDER WAS COMPLETED. NO NONCONFORMITY WAS RAISED DURING THE MANUFACTURING PROCESS OF LOT 9B00938. THIS IN THE ONLY COMPLAINT RAISED FOR THE AFFECTED LOT WITHIN TW8.7. A PHOTOGRAPH HAS BEEN RECEIVED AND HAS BEEN EVALUATED IN ACCORDANCE WITH WI-0359. THE PHOTOGRAPH CONFIRMS THE COMPLAINT ISSUE, THE EXPECTED BATCH NUMBER AND CONFIRMS THIS IS A CONVATEC PRODUCT. AWARENESS TRAINING FOR THE COMPLAINT HAS BEEN COMPLETED FOR ALL FOAM OPERATORS AS PART OF RELATED EVENT 1271842. THE INVESTIGATION ASSOCIATED WITH RELATED EVENT 1271842 HAS BEEN APPROVED AND IS COMPLETE. NO ADDITIONAL ACTION IS REQUIRED AND THIS COMPLAINT WILL BE CLOSED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. THIRD PARTY MANUFACTURING SITE: 2320643.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (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).

    Description of Event or Problem · 1

    IT WAS REPORTED " HYDROCOLLOID PORTION ON THE HYDROFIBRE PORTION" WAS FOUND IN AN AQUACEL FOAM DRESSING. THE PRODUCT WAS NOT USED ON OR BY A PATIENT. PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573347 AQUACEL FOAM DRESSING,WOUND,HYDROPHILIC NAC CONVATEC INC 420804 9B00938

    Patients

    Seq Age Sex Outcome Treatment
    1