BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRINEO SKIN CLOSURE SYSTEM

    MDR report key: 3833310 · Received May 27, 2014

    Report

    Report Number
    2210968-2014-06681
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 5, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    OMD
    PMA / PMN Number
    K082289
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2014 AND A SURGICAL SEALANT WAS USED. APPROXIMATELY 1 TO 2 DAYS POST OP THE PATIENT EXPERIENCED BLEEDING AND OOZING AT THE INCISION SITE. THE PATIENT WAS ON ANTICOAGULANT THERAPY. THE BLEEDING CONTINUED FOR 3 DAYS. ON DAY 4 THE ANTICOAGULANT THERAPY WAS DISCONTINUED AND THE KNEE WAS IMMOBILIZED. THE BLEEDING AND OOZING CONTINUED. APPROXIMATELY 7 TO 10 DAYS POST OP THE SURGICAL SEALANT WAS REMOVED AND THE INCISION WAS REINFORCED WITH STAPLES. ON (B)(6) 2014 THE PATIENT RETURNED TO THE EMERGENCY ROOM WITH A PULMONARY EMBOLISM. THE PATIENT WAS TREATED AND RELEASED FROM THE HOSPITAL ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310702 PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT OMD ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R