BEUDAMED
    FDA Adverse Event Summary report: N

    DUODERM® HYDROACTIVE® GEL, STERILE- 30 GRAMS

    MDR report key: 6046283 · Received October 21, 2016

    Report

    Report Number
    1000317571-2016-00084
    Date Received
    October 21, 2016
    Date of Event
    October 4, 2016
    Report Date
    October 5, 2016
    Manufacturer
    CONVATEC LIMITED
    Product Code
    NAE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BATCH RECORD REVIEW INDICATES NO DISCREPANCIES HOWEVER THE LABOUR SHEETS CONFIRM TUBE JAMS AND DENTS DURING MANUFACTURING OF THE ASSOCIATED BATCH. PRODUCT MAINTENANCE WAS COMPLETED TO SCHEDULE. THERE WERE NO ISSUES RELATING TO THE REPORTED COMPLAINT IN THE MACHINE LOGS. ADDITIONAL TRAINING REQUIREMENTS WERE IDENTIFIED. A NONCONFORMANCE HAS BEEN INITIATED TO FURTHER INVESTIGATE THE ISSUE. THE COMPLAINT WILL REMAIN OPEN UNTIL THE INVESTIGATION IS APPROVED AND COMPLETE. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE - 09/2018. DEVICE MANUFACTURE DATE - 09/2015. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4). NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TUBE PRESENT CRACKS DURING USE, THEREFORE IT IS DIFFICULT TO USE THE FULL CONTENT OF THE PRODUCT. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698064 DUODERM® HYDROACTIVE® GEL, STERILE- 30 GRAMS DRESSING, WOUND,HYDROGEL W/OUT DRUG NAE CONVATEC LIMITED 187987 5J01183

    Patients

    Seq Age Sex Outcome Treatment
    1