BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAGEL SURGICAL HEMOSTAT

    MDR report key: 2479122 · Received February 24, 2012

    Report

    Report Number
    2530131-2012-00004
    Event Type
    Injury
    Date Received
    February 24, 2012
    Report Date
    January 31, 2012
    Manufacturer
    STRYKER ORTHOBIOLOGICS
    Product Code
    LMF
    PMA / PMN Number
    P050044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFO REGARDING DEVICE PART NUMBER OR LOT NUMBER IS AVAILABLE, THEREFORE NO BATCH RECORD REVIEW COULD BE COMPLETED. A COMPLAINT HISTORY REVIEW REVEALED TWO REPORTED SEROMAS BEYOND THESE CASES, HOWEVER NO SIMILAR COMPLAINTS HAVE BEEN REPORTED SINCE 2007. THE PHYSICIAN WAS INITIALLY CONTACTED ON (B)(6) 2012 AND A MEETING WAS SCHEDULED FOR (B)(6) 2012. THE PHYSICIAN CANCELED THE MEETING ON (B)(6) 2012 AND A RESCHEDULING IS CURRENTLY IN PROCESS. SHOULD ANY FURTHER INFO BECOME AVAILABLE, A F/U REPORT WILL BE FILED. IT IS NOT KNOWN WHETHER THESE ADVERSE EVENTS (THIS EVENT AND 253013-2012-00005) ARE DEVICE RELATED. SEROMA IS A NOTED RISK OF PROCEDURES USING THE DEVICE AND IS APPROPRIATELY CATEGORIZED IN THE DEVICE'S RISK ASSESSMENT. SEROMA IS NOTED AS A POTENTIAL ADVERSE EVENT IN THE INSTRUCTIONS FOR USE AND WAS A NOTED ADVERSE EVENT IN THE (B)(6) CLINICAL TRIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO SEROMAS DEVELOPED IN TWO DIFFERENT PTS AFTER A PROCEDURE UTILIZING VITAGEL. THE NATURE OF THE PROCEDURES ARE UNK, BUT WHERE RELATED TO THE THYROID. BOTH SEROMAS WERE DRAINED APPROX ONE WEEK OUT OF SURGERY. NO OTHER COMPLICATIONS WERE REPORTED. THIS IS THE FIRST OF TWO REPORTS FOR THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAGEL SURGICAL HEMOSTAT ABSORBABLE, HEMOSTAT, COLLAGEN BASED LMF STRYKER ORTHOBIOLOGICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention