BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL HEMOSTATIC MATRIX

    MDR report key: 4116096 · Received September 24, 2014

    Report

    Report Number
    2032282-2014-00131
    Event Type
    Injury
    Date Received
    September 24, 2014
    Report Date
    September 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    LMF
    PMA / PMN Number
    P990009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DUE TO THE LACK OF INFORMATION, THIS CASE IS CURRENTLY NOT ASSESSABLE AND 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE AUTHOR TO RETRIEVE ADDITIONAL CLINICAL DETAILS. NO RESPONSE WAS RECEIVED. BAXTER HAYWARD COMPLETED THE INVESTIGATION. AS NEITHER THE LOT NUMBER NOR SAMPLE WERE PROVIDED, NO BATCH REVIEW OR SAMPLE EVALUATION WAS POSSIBLE. A REVIEW OF DETAILS OF THE COMPLAINT INDICATED THAT NO FURTHER INVESTIGATION IS REQUIRED. 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.

    Description of Event or Problem · 1

    PATIENT 2 OF 3: FROM LITERATURE: CENK GURBUZ, ET. AL. "OFF-CLAMP LAPAROSCOPIC PARTIAL NEPHRECTOMY FOR A LOW RENAL NEPHROMETHRY SCORED PATIENTS". A-18. INTRODUCTION AND OBJECTIVES: BECAUSE OF THE IMPACT WARM ISCHEMIA TIME MAY HAVE ON RENAL FUNCTION, VARIOUS SURGICAL TECHNIQUES HAVE BEEN PROPOSED TO MINIMIZE OR ELIMINATE WARM ISCHEMIA. THE OBJECTIVE OF THIS STUDY IS TO EVALUATE OUR INITIAL OUTCOMES OF TRANS OR RETROPERITONEAL PARTIAL NEPHRECTOMY (R/TLPN) PERFORMED BY OFF-CLAMP EXCISION. METHODS: BETWEEN AUGUST 2012 AND MARCH 2014, 41 CONSECUTIVE PATIENTS UNDERWENT OFF CLAMP R/TLPN AT OUR INSTITUTION. AFTER EXCISION OF TUMOR, RENORRHAPHY PLUS BIOLOGIC HEMOSTATICS FLOSEALÔ (BAXTER HEALTHCARE CORP., (B)(4)) WERE PERFORMED. RESULTS: MAJORITY OF THE PATIENTS (39) WERE NOTED TO HAVE A LOW (4¿6) RENAL NEPHROMETHRY SCORE (RNS) AND 2 PATIENTS HAD A MODERATE (7¿9) RNS. NO HILAR LOCATION TUMOR WAS NOTED. THE MEAN TUMOR SIZE AMONG THIS COHORT WAS 33.1 (RANGE, 2.0¿6.0) CM, AND THE MEAN ESTIMATED BLOOD LOSS WAS 266 (RANGE, 70¿500)ML. ONE PATIENT REQUIRED BLOOD TRANSFUSION. OPEN CONVERSION WAS NEEDED IN 1 PATIENT. THE MEAN HOSPITAL STAY WAS 2.9 (RANGE, 2¿5) DAYS. THE MEAN PERCENTAGE OF POSTOPERATIVE ESTIMATED GLOMERULAR FILTRATION RATE CHANGE INCREASED BY 0.8%. TWO PATIENTS WITH GRADE III COMPLICATION BY THE CLAVIEN-DINDO CLASSIFICATION WERE TREATED BY ENDOSCOPIC INTERVENTION. SURGICAL MARGIN WAS NOTED POSITIVE IN 3 PATIENTS. CONCLUSIONS: OUR INITIAL EXPERIENCE WITH OFF-CLAMP LPN DEMONSTRATES ENCOURAGING RESULTS OF MINIMAL RENAL FUNCTION LOSS AND COMPLICATIONS IN PATIENTS WITH A LOW RNS. TWO (2) PATIENTS GRADE III CLAVIEN COMPLICATIONS. ONE (1) PATIENT REQUIRED CONVERSION TO OPEN SURGERY. (THIS COMPLAINT IS REGARDING ONE OF TWO PATIENTS WITH GRADE III CLAVIEN COMPLICATIONS.) NOTE: THE OCCURRENCE DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594798 FLOSEAL HEMOSTATIC MATRIX AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMF BAXTER HEALTHCARE - HAYWARD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other