BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL HEMOSTATIC MATRIX

    MDR report key: 3982150 · Received August 5, 2014

    Report

    Report Number
    2032282-2014-00115
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    LMF
    PMA / PMN Number
    P990009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE REPORTER TO RETRIEVE ADDITIONAL CLINICAL DETAILS. NO RESPONSE WAS RECEIVED. BAXTER (B)(4) COMPLETED THE INVESTIGATION. SAMPLE EVALUATION COULD NOT BE PERFORMED AS NO SAMPLE WAS AVAILABLE. BATCH RECORD REVIEW COULD NOT BE PERFORMED AS THE BATCH NUMBER WAS UNKNOWN. NO TREND WAS IDENTIFIED. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER TIME, THE INFORMATION WILL BE EVALUATED AND A FOLLOW-UP SUBMISSION WILL BE SENT. THIS CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). DUE TO THE LACK OF INFORMATION, THE CASE IS NOT CURRENTLY ASSESSABLE AND THIS CASE IS BEING CONSERVATIVELY REPORTED. BAXTER IS CURRENTLY IN THE PROCESS OF FOLLOWING UP WITH THE REPORTER FOR ADDITIONAL INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER SALES REP FROM A SURGEON THAT DURING A SPINE SURGERY/SPINE FUSION, ONE OF HIS PATIENTS EXPERIENCED ANAPHYLAXIS AFTER USE OF FLOSEAL. THE SURGEON STATED THEY HAD A TOUGH TIME BRINGING HER BACK OUT, BUT SHE WAS BROUGHT BACK AND WAS FINE. THE SURGEON STATED THERE WAS NO LONG LASTING EFFECTS AND THE EVEN HAPPENED EARLIER THIS YEAR. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456850 FLOSEAL HEMOSTATIC MATRIX AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMF BAXTER HEALTHCARE - HAYWARD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other