BEUDAMED
    FDA Adverse Event Other Summary report: N

    OCTYLSEAL

    MDR report key: 2210097 · Received July 30, 2011

    Report

    Report Number
    1417592-2011-00044
    Event Type
    Other
    Date Received
    July 30, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 28, 2011
    Manufacturer
    CHEMENCE MEDICAL PRODUCTS, INC.
    Product Code
    MPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A SURGICAL PLACEMENT OF AN IMPLANTABLE PORT, THE INCISION WAS CLOSED WITH THE SURGICAL ADHESIVE. THE SITE WAS THEN COVERED WITH A DRESSING. THE PT RETURNED FOR A POST OP VISIT. AS THE CLINICIAN WAS REMOVING THE SURGICAL DRESSING, THE ADHESIVE WAS FOUND TO BE STUCK TO THE DRESSING. UPON REMOVAL, A WOUND DEHISCENCE AND SUBSEQUENT INFECTION RESULTED. THE PT WAS TAKEN BACK TO SURGERY AND THE PORT WAS REPLACED. THE CLINICIAN ACKNOWLEDGED THAT THE ADHESIVE MAY NOT HAVE BEEN COMPLETELY DRY AT THE TIME THE SURGICAL SITE WAS DRESSED. THE INSTRUCTIONS CLEARLY STATE THAT A PROTECTIVE DRY DRESSING MAY BE APPLIED ONLY AFTER THE ADHESIVE FILM IS COMPLETELY SOLID AND NOT TACKY TO THE TOUCH. IT ALSO STATES THAT IF THE DRESSING IS APPLIED BEFORE COMPLETE POLYMERIZATION, THE DRESSING CAN ADHERE TO THE FILM. BASED ON THE INFO GATHERED, WE HAVE DETERMINED THAT USER ERROR WAS THE MAJOR CONTRIBUTING FACTOR TO THE INCIDENT. WE HAVE NO INFO SUGGESTING THAT THE PRODUCT DID NOT PERFORM AS INTENDED. NO CORRECTIVE ACTIONS TO BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE SURGICAL ADHESIVE STUCK TO THE POST OP DRESSING. UPON REMOVAL OF THE DRESSING, A WOUND DEHISCENCE AND SUBSEQUENT INFECTION RESULTED AND THE IMPLANTED PORT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTYLSEAL TISSUE ADHESIVE MPN CHEMENCE MEDICAL PRODUCTS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention