BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SVEDMAN WOUND TREATMENT SYSTEM

    MDR report key: 1644652 · Received March 30, 2010

    Report

    Report Number
    3006367520-2010-00001
    Event Type
    Injury
    Date Received
    March 30, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 26, 2010
    Manufacturer
    INNOVATIVE THERAPIES, INC.
    Product Code
    OMP
    PMA / PMN Number
    K070904
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ITI IS FILING THIS REPORT DUE TO POSSIBLE USE ERROR AS THE (B) (4) TREATMENT DRESSING WAS NOT IRRIGATED OR MONITORED AS RECOMMENDED IN THE (B) (4) WOUND TREATMENT SYSTEM DRESSING APPLICATION PRECAUTIONS FOR INFECTED WOUNDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE DRESSING CHANGE ON (B) (6) 2010, THE PT'S WOUND WAS INFECTED AND THE EXUDATE HAD PLUGGED THE PORES OF THE DRESSING AND FLUID WAS NOT BEING REMOVED. THE PT WAS MOVED INTO ICU FOR TREATMENT OF POSSIBLE SEPSIS. THE PT'S PHYSICIAN REPORTED THAT THE WOUND APPEARED TO BE PROGRESSING WELL AT THE DRESSING CHANGE ON (B) (6) 2010, BUT THERE WERE NO RECORDS OF THE QUANTITY OF EXUDATE PRODUCTION OR RECORDS OF DRESSING CHANGES TAKEN OVER THE WEEK-END. THE DEVICE WAS RETURNED FOR EVAL. THE DEVICE WAS TESTED AND MET SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SVEDMAN WOUND TREATMENT SYSTEM POWERED SUCTION PUMP AND DRESSING KIT OMP INNOVATIVE THERAPIES, INC. 67000032

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization