BEUDAMED
    FDA Adverse Event Other Summary report: N

    SVED WOUND TREATMENT SYSTEM

    MDR report key: 2249774 · Received September 9, 2011

    Report

    Report Number
    3006367520-2011-00001
    Event Type
    Other
    Date Received
    September 9, 2011
    Date of Event
    August 16, 2011
    Report Date
    September 9, 2011
    Manufacturer
    INNOVATIVE THERAPIES, INC.
    Product Code
    OMP
    PMA / PMN Number
    K093564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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, BUT TO ENSURE COMPLETE REMOVAL OF BLACK FOAM IN EXTENSIVE UNDERMINING, CONSIDER WRAPPING IT IN A WOUND CONTACT LAYER". ADDITIONAL INSERVICE WAS REQUESTED AND PROVIDED TO REVIEW APPROPRIATE DRESSING APPLICATIONS FOR WOUNDS WITH UNDERMINING AND TUNNELS. THERE WAS NO PRODUCT MALFUNCTION. THIS REPORT IS BEING FILED DUE TO USER MISUSE.

    Description of Event or Problem · 1

    A WOUNDCARE NURSE REPORTED TO AN ITI REPRESENTATIVE THAT SHE HAD A PATIENT WHERE THE BLACK FOAM BECAME EMBEDDED IN THE WOUND. THE NURSE REPORTED THAT THE LAST DRESSING CHANGE WAS ON (B)(6) SHE WAS UNABLE TO REMOVE THE FOAM. THE NURSE SAID SHE EXERTED QUITE A BIT OF FORCE WITHOUT SUCCESS. SHE WAS RELUCTANT TO PULL HARDER IN CASE SHE CAUSED BLEEDING. THE ITI REPRESENTATIVE WAS ABLE TO VIEW THE WOUND AND DETERMINED THAT BLACK FOAM WAS USED IN AN UNDERMINED AREA AND ALSO NOTED A TUNNEL AREA ABOUT 8 CM LONG THAT WAS ALSO PACKED WITH BLACK FOAM. SURGICAL DEBRIDEMENT WAS PERFORMED ON (B)(6) AND THE PATIENT RETURNED HOME THE FOLLOWING DAY, REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SVED WOUND TREATMENT SYSTEM POWERED SUCTION PUMP AND DRESSING KIT OMP INNOVATIVE THERAPIES, INC. 67001132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention