BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL

    MDR report key: 1891753 · Received November 5, 2010

    Report

    Report Number
    2954761-2010-00040
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    LMF
    PMA / PMN Number
    P990009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE REPORTER, BUT NO RESPONSE HAS BEEN RECEIVED. AS SURGIFLO MAY ALSO HAVE BEEN USED, ETHICON / JOHNSON AND JOHNSON HAS BEEN MADE AWARE OF THIS CASE.AS BIOGLUE MAY ALSO HAVE BEEN USED, CRYOLIFE HAS BEEN MADE AWARE OF THIS CASE.THIS CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: TOO SLOW, HESITANT APPLICATION AND/OR APPROXIMATION OF FLOSEAL MAY INDUCE BLOOD IMBIBITION OF THE GELATIN MATRIX, CREATING A SOLIDIFIED MASS OF EXCESSIVE PRODUCT. BASED ON THE EXISTING INFORMATION THIS IS NOT YET CONFIRMED. THE CURRENT INFORMATION DOES NOT ALLOW THE EVALUATION OF A CAUSAL RELATIONSHIP TO THE APPLICATION OF FLOSEAL. (B)(4). BAXTER IS IN THE PROCESS OF FOLLOWING UP WITH THE SURGEON TO OBTAIN ADDITIONAL EVENT DETAILS. THIS CASE IS BEING CONSERVATIVELY REPORTED TO MEETING REPORTING DEADLINES. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    REOPERATION ON A (B)(6) PATIENT FOR AN ARTERIAL SWITCH. WHEN SURGEON OPENED THE CHILD, HE FOUND A ROCK-LIKE MASS THAT WAS IN THE AREA WHERE HE APPLIED FLOSEAL. AT THIS POINT IN TIME, THE CHILD IS STILL IN THE ICU. THE BAXTER REPRESENTATIVE HAD ATTEMPTED TO GET A HOLD OF THE SURGEON, BUT HAS NOT RECEIVED A RESPONSE. BIOGLUE AND SURGIFLO IS ALSO USED AT THE HOSPITAL. ACCORDING TO THE BAXTER REPRESENTATIVE, THE OTHER PRODUCTS MAY HAVE BEEN USED ALSO. THIS SURGERY WAS A RE-EXPLORATION FOR A SURGERY THAT WAS PERFORMED (B)(6) 2010. THE PURPOSE AND TYPE OF SURGERY PERFORMED ON (B)(6) 2010 IS UNKNOWN AT THIS TIME. ADDITIONAL INFORMATION RECEIVED FROM THE BAXTER REPRESENTATIVE ON (B)(4) 2010: THE PATIENT SURVIVED THE PROCEDURE AND IS IN THE ICU ON WHAT HAPPENS TO BE A LVAD. BAXTER IS CURRENTLY ATTEMPTING TO CONTACT THE SURGEON FOR ADDITIONAL EVENT DETAILS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| O