BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3W1275 - DUODERM PASTE AND GELS

    MDR report key: 11892919 · Received May 27, 2021

    Report

    Report Number
    1000317571-2021-00162
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Report Date
    April 30, 2021
    Manufacturer
    CONVATEC LTD
    Product Code
    NAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION (G1) - CONTACT OFFICE ADDRESS: (B)(6) A BATCH RECORD REVIEW INDICATES NO DISCREPANCIES. PM LOGS HAVE BEEN CHECKED AND ALL PM'S HAVE BEEN COMPLETED WITH NO DISCREPANCIES FOUND. AFFECTED AMOUNT: 13PCS DUODERM PASTE 30G WAS MANUFACTURED UNDER SAP CODE 1000894 AND MANUFACTURING LOT NUMBER 9M00772. LOT # 9M00772 WAS STERILIZED UNDER LOT 2173-7093A AND RELEASED ON REVIEW OF RESULTS OF STERILIZATION PROVIDED BY STERILIZATION COMPANY STERIS. ALL OF THE RESULTS WERE WITHIN SPECIFICATION AND PRODUCTS WERE RELEASED. THE PRODUCTION PROCESS, IN PROCESS TESTING AND PACKAGING OF PRODUCTS WAS RUN IN ACCORDANCE WITH PI12-021 VER. 25.0 FOR PASTE. VISUAL INSPECTION IN ACCORDANCE WITH PR20-009 WAS COMPLETED AT THE BEGINNING OF THE ORDER AND EVERY HOUR FOLLOWING UNTIL THE ORDER WAS COMPLETED. NO NONCONFORMITY WAS REGISTERED WITHIN THE MANUFACTURING PROCESS OF LOT 9M00772. THIS IS THE ONLY COMPLAINT FOR THE AFFECTED LOT REGISTERED WITHIN TW8.7. 2 PHOTOGRAPHS HAVE BEEN RECEIVED FOR THIS ISSUE AND HAVE BEEN REVIEWED IN ACCORDANCE WITH WI-0359. THE PHOTOGRAPHS CONFIRM THE PRODUCT EXPECTED AND THE COMPLAINT ISSUE. THE ISSUE APPEARS TO BE EXCESS PASTE WITHIN THE CRIMP OF THE TUBE AND HAS LEAKED ONTO THE TUBE. DUODERM PASTE HAS SINCE BEEN DISCONTINUED AND THE LINE HAS BEEN REMOVED FROM DEESIDE. 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

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

    Additional Manufacturer Narrative · 1

    MDR 1000317571-2021-00162 / DEVICE 3 OF 13 COMPLAINANT CITY: (B)(6) COMPLAINANT PHONE: (B)(6) PATIENT COUNTRY: (B)(6) CONTACT OFFICE ADDRESS: (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 · 1

    IT WAS REPORTED THAT THE CONTENTS OF AN UNKNOWN NUMBER OF TUBES IN THE 13 BOXES HAD LEAKED, WHICH MADE ALL 13 BOXES GREASY AND THEREFORE UNSELLABLE. THE PRODUCTS WERE NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791911 L3W1275 - DUODERM PASTE AND GELS NOT APPLICABLE NAD CONVATEC LTD 187930 9M00772

    Patients

    Seq Age Sex Outcome Treatment
    1