BEUDAMED
    FDA Adverse Event Other Summary report: N

    ITI DRESSING SETS FOR USE WITH ITI WTS

    MDR report key: 2426239 · Received January 19, 2012

    Report

    Report Number
    3006367520-2011-00002
    Event Type
    Other
    Date Received
    January 19, 2012
    Date of Event
    December 30, 2011
    Report Date
    January 20, 2012
    Manufacturer
    INNOVATIVE THERAPIES, INC.
    Product Code
    OMP
    PMA / PMN Number
    K093564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ATTENDING PHYSICIAN REPORTED THE PT EXPERIENCED NO HARM FROM THE FEW PIECES OF FOAM HE FOUND WHEN EXPLORING THE WOUND. HE WAS PLANNING TO TAKE THE PT BACK TO SURGERY ANYWAY. IN HIS OPINION, THERE WAS NO DEVICE FAILURE BUT RATHER THE HEALTHCARE PROVIDER ACTED OUTSIDE OF THE CLINICAL GUIDELINES. ITI'S DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES "DO NOT USE BLACK FOAM IN TUNNELS" AND "BLACK FOAM MAY BE USED IN UNDERMINING, CONSIDER WRAPPING IT IN A WOUND CONTACT LAYER". THIS REPORT IS BEING FILED DUE TO USER MISUSE.

    Description of Event or Problem · 1

    AN ITI REPRESENTATIVE REPORTED THAT DURING A ROUTINELY SCHEDULED PICK-UP, THE PT'S HUSBAND STATED THAT HIS WIFE WAS SCHEDULED TO HAVE SURGERY, ALLEGEDLY DUE TO STUFF LEFT INSIDE OF HER. THE ATTENDING NURSE REPORTED TO ITI'S CLINICAL DIRECTOR THAT THE WOUND ALLEGEDLY HEALED SO FAST THAT IT HEALED RIGHT OVER THE FOAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITI DRESSING SETS FOR USE WITH ITI WTS ITI BLACK FOAM DRESSING OMP INNOVATIVE THERAPIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention