BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SVED WOUND TREATMENT SYSTEM

    MDR report key: 3282476 · Received August 5, 2013

    Report

    Report Number
    3006367520-2013-00001
    Event Type
    Injury
    Date Received
    August 5, 2013
    Date of Event
    July 1, 2013
    Report Date
    August 3, 2013
    Manufacturer
    INNOVATIVE THERAPIES, INC.
    Product Code
    OMP
    PMA / PMN Number
    K093564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ITI HAS BEEN UNABLE TO OBTAIN SUFFICIENT INFO TO CONFIRM THE ALLEGED EVENT. ITI HAS ESTABLISHED WEEKLY REVIEW OF THE DEVICE USE AND DRESSING APPLICATION WITH THE FACILITY'S WOUND CARE STAFF. ITI ALSO PROVIDES 24/7 CLINICAL CUSTOMER SERVICE FOR CLINICIANS IF HAVING ANY DEVICE OR DRESSING APPLICATION ISSUES. SINCE THE REPORT WAS RECEIVED ON (B)(6), NO ADDITIONAL INFO HAS BEEN PROVIDED EITHER FROM INQUIRY NOR DURING THE TRAINING SESSIONS WITH THE WOUND CARE STAFF. THIS REPORT IS SUBMITTED, AS A GOOD FAITH EFFORT TO REPORT WITHIN THE 30-DAY REQUIREMENT. A FOLLOW-UP REPORT WILL BE SUBMITTED, IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT "HAD A VAC ON AND IT WAS NOT PICKING UP THAT THERE WAS NOT A GOOD SEAL". THE REPORTER ALLEGED THAT THE WOUND WAS FILLED WITH STOOL, THE WOUND WAS 3 TIMES LARGER AND THE PT WAS TO BE MOVED TO ANOTHER FACILITY FOR A FLAP. AFTER NUMEROUS ATTEMPTS TO GATHER ADDITIONAL INFO, AND WITH NO RESPONSES, ITI HAS BEEN UNABLE TO DETERMINE IF THE ALLEGED WOUND DETERIORATION IS RELATED TO THE SVED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366522 SVED WOUND TREATMENT SYSTEM NEGATIVE PRESSURE SUCTION PUMP/DRESSINGS OMP INNOVATIVE THERAPIES, INC. 67001132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention