BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3W1275 - DUODERM PASTE AND GELS

    MDR report key: 11811529 · Received May 12, 2021

    Report

    Report Number
    1000317571-2021-00152
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Report Date
    April 19, 2021
    Manufacturer
    CONVATEC LTD
    Product Code
    NAE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION (G1) - CONTACT OFFICE ADDRESS: DR. (B)(6) . (B)(6) . A BATCH RECORD REVIEW HAS BEEN COMPLETED WITH NO DISCREPANCIES FOUND. PM LOGS HAVE BEEN REVIEWED AND ALL PMS WERE COMPLETED WITH NO DISCREPANCIES FOUND. AFFECTED AMOUNT: (B)(4). DUODERM HYDROACTIVE GEL 30G WAS MANUFACTURED UNDER SAP NUMBER 1002859 AND MANUFACTURING LOT NUMBER 0F01678. LOT # 0F01678WAS STERILIZED UNDER LOT 20F22K9517 NUMBER AND RELEASED ON REVIEW OF RESULTS OF STERILIZATION PROVIDED BY STERILIZATION COMPANY BAXTERS. ALL RESULTS WERE WITHIN SPECIFICATION AND PRODUCTS WERE RELEASED. THE PRODUCTION PROCESS, IN PROCESS TESTING AND PACKAGING OF PRODUCTS WAS RUN IN ACCORDANCE WITH PI12-017 VER.28.0 FOR GEL. VISUAL INSPECTION IN ACCORDANCE WITH PI12-017 WAS COMPLETED AT THE BEGINNING OF THE ORDER AND EVERY 15 MINUTES FOLLOWING UNTIL THE ORDER WAS COMPLETED. NO NONCONFORMITY WAS REGISTERED DURING THE MANUFACTURING PROCESS OF LOT 0F01678. THIS IS THE ONLY COMPLAINT FOR THE AFFECTED LOT REGISTERED WITHIN TW8.7. A PHOTOGRAPH HAS BEEN RECEIVED AND HAS BEEN EVALUATED IN ACCORDANCE WITH (B)(4). THE PHOTOGRAPH CONFIRMS THE EXPECTED PRODUCT BATCH NUMBER AND COMPLAINT ISSUE. THE PHOTOGRAPH SHOWS THE HOLE IS IN THE MEMBRANE SEAL. THE TUBES ARE FILLED FROM THE CRIMP END. THE TUBES ARE ALL HAND PACKED INTO CARTONS AFTER STERILIZATION SO ANY GEL LEAKING WOULD LEAK ONTO THE TUBE. THE GEL LOOKS FRESH AS IT IS STILL CLEAR IN COLOUR. ON TESTS DONE WITH GEL, IF THE GEL LEAKS OUT OF THE TUBE IT TURNS A BROWN COLOUR WITHIN 48 HOURS OF LEAKING. 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

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

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). 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 THAT LID OF THE TUBE WAS FOUND TO BE DAMAGED. THE SEALED MEMBRANE SHOULD BE SEALED BUT FOUND TO BE BROKEN. THE PRODUCT WAS USED ON PATIENT AND NO HARM WAS REPORTED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707593 L3W1275 - DUODERM PASTE AND GELS NOT APPLICABLE NAE CONVATEC LTD 187987 0F01678

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown