BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL MATRIX HEMOSTATIC SEALANT (FLOSEAL MATRIX)

    MDR report key: 5084273 · Received October 27, 2004

    Report

    Report Number
    2954761-2004-01175
    Event Type
    Injury
    Date Received
    October 27, 2004
    Date of Event
    March 11, 2004
    Report Date
    March 22, 2004
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMMENTS: BAXTER INITIALLY RECEIVED THE EVENT ON (B)(6) 2004 AND FOLLOW UP INFO ON (B)(6) 2004. BASED ON THE INFO AT THAT TIME, THERE WAS NO REASONABLE ASSOCIATION OF THE EVENT WITH THE FLOSEAL PRODUCT. THEREFORE, THE EVENT WAS CATEGORIZED AS NON-REPORTABLE. ON (B)(6) 2004 (B)(6), ASSESSED THE CASE AS FOLLOWS: GIVEN THE EXISTING INFO, BOTH CASES FROM THE SAME REPORTER ((B)(4)) HAVE THE SAME MECHANISM AND ROUTE-CAUSE. THE POSTOPERATIVE BLEEDING IS NOT RELATED TO THE USE OF FLOSEAL AND THUS NON REPORTABLE. FLOSEAL HEMOSTATIC MATRIX IS A HIGH-END HEMOSTAT, WITH NO SEALING PROPERTIES. HEMOSTATS HALT BLEEDING, WHILE SEALANTS PREVENT POSTOPERATIVE BLEEDING. IN OTHER WORDS, FLOSEAL IS ABLE TO CONTROL INTRAOPERATIVE BLEEDING, BUT HAS NO IMPACT IN PREVENTING POSTOPERATIVE OCCURING HEMORRHAGE. THUS, THIS PRODUCT IS NOT ADEQUATE, WHEN THE SURGEON IS TRYING TO PREVENT EVENTS OCCURING AFTER SURGICAL CLOSURE. THUS, THE POSTOPERATIVE BLEEDING IS NOT RELATED TO THE APPLICATION OF FLOSEAL, SINCE THIS PRODUCT IS NOT CAPABLE TO PREVENT THIS TYPE OF COMPLICATION. FROM THE CUSTOMERS/REPORTER INTERACTION PERSPECTIVE, THIS SPECIFIC ACCOUNT NEEDS TO BE RETRAINED ON THE PRODUCT PROPERTIES OF FLOSEAL. ON (B)(6) 2004, WHILE UNDERGOING A FDA GMP AUDIT AT THE BAXTER (B)(4) FACILITY WHERE FLOSEAL IS MANUFACTURED, IT WAS THE FDA AUDITOR'S OPINION THAT THIS EVENT SHOULD BE REPORTED AS A 30 DAY MDR. THEREFORE, BAXTER IS SUBMITTING THIS EVENT AS A 30 DAY MDR.

    Description of Event or Problem · 1

    THIS IS ONE OUT OF TWO SPONTANEOUS CASE REPORTS RECEIVED BY BAXTER (B)(4) ((B)(4)) FROM A HOSPITAL UROLOGIST VIA A SALES REPRESENTATIVE. THE BAXTER MFR. NUMBER OF THE OTHER CASE IS (B)(4). THIS CASE REFERS TO A (B)(6) MALE PT ((B)(6)) WHO UNDERWENT A PARTIAL NEPHRECTOMY (RIGHT KIDNEY) ON (B)(6) 2004 (AT NOON). DUE TO THIS SURGERY FLOSEAL (LOT NUMBER 031201), DOSAGE UNK) WAS GIVEN. DURING SURGERY, AFTER INITIAL SUFFICIENT HEMOSTASIS, THE PT DEVELOPED A SECONDARY BLEEDING BEFORE THE NEPHRECTOMY WAS FINISHED. CONVENTIONAL TREATMENT WITH TABOTAMP (ABSORBABLE HEMATOSTATIC) WAS INITIATED. THE INITIAL REPORT AND A FOLLOW UP INFO ((B)(6) 2004) ARE CONTRADICTORY WITH REFERENCE TO THE ADMINISTRATION OF AN UNK NUMBER OF BLOOD TRANSFUSIONS. NO PROLONGED HOSPITALIZATION WAS NECESSARY. THE PT RECOVERED COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOSEAL MATRIX HEMOSTATIC SEALANT (FLOSEAL MATRIX) HEMOSTATIC SEALANT LMF BAXTER HEALTHCARE CORPORATION NA 031201

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR