BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING

    MDR report key: 10574967 · Received September 23, 2020

    Report

    Report Number
    1000317571-2020-00049
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Report Date
    September 10, 2020
    Manufacturer
    CONVATEC LTD
    Product Code
    NAE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A BATCH RECORD REVIEW INDICATES NO DISCREPANCIES. PM LOGS HAVE BEEN CHECKED AND ALL PM'S WERE COMPLETED. AFFECTED AMOUNT: 1PC. DUODERM H/ACTIVE GEL 30G WAS MANUFACTURED UNDER SAP CODE1002859 AND MANUFACTURING LOT NUMBER 0C00799. LOT NUMBER 0C00799 WAS STERILIZED UNDER LOT 20C16K6318 AND RELEASED ON REVIEW OF RESULT OF STERILIZATION PROVIDED BY STERILIZATION COMPANY BAXTERS. 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 PI12-017 VER. 28.0 FOR GEL. VISUAL INSPECTION IN ACCORDANCE WITH PR20-011 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 0C00799. THIS IS THE ONLY COMPLAINT FOR THE AFFECTED LOT REGISTERED WITHIN TW 8.7. A PHOTOGRAPH HAS BEEN RECEIVED FOR THIS ISSUE AND HAS BEEN EVALUATED IN ACCORDANCE WITH WI-0359. THE PHOTOGRAPH CONFIRMS THE LOT NUMBER AND PRODUCT EXPECTED. IT ALSO CONFIRMS THE COMPLAINT ISSUE. GEL IS PACKED BY HAND TO GO TO THE STERILIZATION PLANT AND THEN IS HAND PACKED INTO CARTONS FOR DISTRIBUTION. IF ANY GEL WERE TO LEAK IT WOULD BE FELT BY THE OPERATORS WHEN PACKING THE TUBES INTO CARTONS. THE GEL LEAKING IN THE PHOTOGRAPHS LOOKS FRESH AND CLEAR. WHEN TESTED WITH A PIN HOLE CREATED IN A TUBE AND GEL SQUEEZED OUT THE GEL GOES HARD AND A BROWN COLOUR OUTSIDE OF THE TUBE WITHIN 24 HOURS. THERE APPEARS TO BE NO BROWN GEL RESIDUE ON THE TUBE IN THE PHOTOGRAPH RECEIVED. OPERATIONS HAVE BEEN MADE AWARE OF THE COMPLAINT ISSUE. 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 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 ¿FOUND THE TUBE GET PUNCTURED SO, THERE IS A HOLE.¿ NO HARM WAS REPORTED. A PHOTOGRAPH DEPICTING THE REPORTED COMPLAINT ISSUE WAS PROVIDED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039779 DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC NAE CONVATEC LTD 187987 0C00799

    Patients

    Seq Age Sex Outcome Treatment
    1