BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL HEMOSTATIC MATRIX

    MDR report key: 2191234 · Received August 4, 2011

    Report

    Report Number
    2954761-2011-00047
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    LMF
    PMA / PMN Number
    P990009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE REPORTER IN AN EFFORT TO RECEIVE ADDITIONAL CASE INFORMATION. NO RESPONSE WAS RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER TIME, THE INFORMATION WILL BE EVALUATED AND A FOLLOW-UP SUBMISSION WILL BE SENT. THIS COMPLAINT WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: THIS IS A SINGLE CASE REPORT OF AN INCORRECT APPLICATION TECHNIQUE WITH FAILURE TO IRRIGATE EXCESS MATRIX DURING A NON-INDICATED USE (OPHTHALMIC) OF FLOSEAL HEMOSTATIC MATRIX. IT IS LOGICAL THAT THE FLOSEAL MATRIX LEFT THROUGHOUT THE NEWLY CREATED TRACK BETWEEN THE TEAR DUCT AND THE NASAL CAVITY WOULD BLOCK THIS DUCT, AT LEAST TEMPORARILY. THERE IS ALSO AT LEAST A POSSIBILITY OF THIS BLOCKAGE BEING LONG TERM THROUGH ADHESION FORMATION ACROSS THE BLOOD SOAKED MATRIX, AS REPORTED DURING NASAL SINUS SURGERY WHEN IRRIGATION WAS LACKING. DISCUSSION WITH THE SURGEON IS REQUIRED TO ASCERTAIN WHAT THE INTENDED USE OF FLOSEAL WAS DURING THIS PROCEDURE AND ENSURE A SOLID UNDERSTANDING OF THE LABELED INDICATION FOR USE (HEMOSTASIS AND NOT STRUCTURAL SUPPORT TO KEEP THE DUCT PATENT), ALONG WITH THE CORRECT PRODUCT APPLICATION TECHNIQUE (METICULOUS IRRIGATION). UNTIL CLARIFICATION OF THE FOLLOWING INFORMATION IS KNOWN, AN ASSESSMENT CANNOT BE COMPLETED. INTENDED USE OF FLOSEAL. TREATMENT OF BLOCKED DUCT POST OPERATIVELY. CURRENT PATIENT STATUS. (B)(6). DUE TO THE LACK OF INFORMATION, THIS CASE IS BEING CONSERVATIVELY REPORTED. BAXTER IS CURRENTLY IN THE PROCESS OF FOLLOWING UP WITH THE SURGEON FOR ADDITIONAL INFORMATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    PHYSICIAN STATES THAT HE USED FLOSEAL FOR THE FIRST TIME (B)(6) 2011 FOR A DACRYOCYSTORHINOSTOMY. HE STATES THAT HE DID NOT FLUSH THE MATERIAL OUT AFTER USING FLOSEAL AND THE DUCT IS CLOGGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other