BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREVENA INCISION MANAGEMENT SYSTEM

    MDR report key: 2160641 · Received July 7, 2011

    Report

    Report Number
    1625774-2011-00087
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K100821
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK WHETHER USE OF PREVENA MAY HAVE CONTRIBUTED TO THIS EVENT. WE ARE FILING THIS REPORT BECAUSE A POSSIBLE CONTRIBUTION DUE TO USE ERROR CANNOT BE ENTIRELY RULED OUT DUE TO LIMITED INFO PROVIDED. THE TREATING SURGEON HAS DECLINED TO PROVIDE ADDITIONAL INFO REGARDING THE REPORTED EVENT. KCI IS UNABLE TO DETERMINE WHETHER THE PREVENA WAS APPLIED TO A CLEAN CLOSED INCISION AS INDICATED IN PRODUCT LABELING OR ON AN OPEN WOUND, CONTRARY TO PRODUCT INDICATIONS FOR USE. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES THE PREVENA INCISION MANAGEMENT SYSTEM SHOULD NOT BE USED TO TREAT OPEN OR DEHISCED SURGICAL WOUNDS OR ON PTS WHO HAVE EXCESSIVE AMOUNTS OF EXUDATE FROM THE INCISION AREA WHICH MAY EXCEED THE PREVENA 45ML CANISTER.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS REPORTED TO KCI: ON AN UNK DATE, PREVENA WAS DISCONTINUED AFTER 5 DAYS. IT WAS REPORTED THAT THE WOUND HAD FLUID AND A FOUL ODOR WITH POSSIBLE SKIN MACERATION. WHETHER OR NOT THESE REPORTED OBSERVATIONS EXISTED PRIOR TO THERAPY APPLICATION IS UNCONFIRMED. IT WAS REPORTED THAT THE WOUND SITE MAY HAVE HAD INFECTION PRESENT. ADDITIONAL INFO WAS RECEIVED ON (B)(6) 2011, THE KCI REPRESENTATIVE REPORTED THAT THE PHYSICIAN COULD NOT RULE OUT POSSIBILITY THAT COMPLICATIONS MAY BE ATTRIBUTED TO THE PREVENA NOT WORKING PROPERLY BUT WAS UNABLE TO PROVIDE FURTHER INFO AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREVENA INCISION MANAGEMENT SYSTEM OMP KCI USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention