BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMA+FLEX QS

    MDR report key: 3896518 · Received May 19, 2014

    Report

    Report Number
    3010034760-2014-00002
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Report Date
    May 18, 2014
    Manufacturer
    CHEMENCE MEDICAL PRODUCTS INC.
    Product Code
    MPN
    PMA / PMN Number
    K101276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION DETERMINED THAT THE DEVICE WAS USED FOR PORT PLACEMENT, WHICH IS OFF LABEL USE SINCE THE EDGES OF THE WOUND CANNOT BE EASILY APPROXIMATED PRIOR TO WOUND CLOSURE. THE DEVICE WAS NOT RETURNED, LOT NUMBER NOT PROVIDED NOR WAS ANY ADDITIONAL INFORMATION ABOUT THIS SPECIFIC EVENT PROVIDED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    FOLLOWING PORT PLACEMENT, PT RETURNED BACK TO IR FOR FOLLOW UP BECAUSE INCISION HAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297820 DERMA+FLEX QS TISSUE ADHESIVE MPN CHEMENCE MEDICAL PRODUCTS INC. QS 70806 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention