BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL MATRIX HEMOSTATIC SEALANT

    MDR report key: 925920 · Received October 8, 2007

    Report

    Report Number
    2954761-2007-00032
    Event Type
    Injury
    Date Received
    October 8, 2007
    Date of Event
    November 2, 2006
    Report Date
    October 8, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAXTER MEDICAL DIRECTOR ASSESSMENT: SEPT. 15, 2007. MEDDRA TERMS: INFECTION; POSTSURGICAL WOUND INFECTION POSTSURGICAL INFECTION IS A KNOWN COMPLICATION IN FRACTURES WITH OPEN REDUCTION INTERNAL FIXATION WITH SYNTHES LOCKING CONDYLAR PLATE AND INSTRUMENTATION WITHOUT THE USE OF FLOSEAL. FROM THE EXISTING DATA IT SEEMS IMPLAUSIBLE THAT FLOSEAL MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. FURTHER INVESTIGATION: FOLLOW UP MEDICAL QUESTIONS: PRESENCE OF INFECTION PREOPERATIVELY. WAS THE FRACTURE OPEN OR THE WOUND CONTAMINATED? PREOP. LAB PARAMETERS INDICATIVE FOR INFECTION (WBC, CRP, ETC) PRE AND POSTOPERATIVE? TO RULE OUT THAT FLOSEAL CONTRIBUTE OR CAUSED THE INFECTION, BACTERIOLOGIC DATA FROM THE RESPECTIVE LOT # 060801 IS RECOMMENDED. INVESTIGATION IF OTHER INFECTION REPORTS OCCURRED WITH THIS SAME LOT # (060801). CUSTOMER RETRAINING NOT REQUIRED. RAYMOND F. NISTOR, MD BIOSURGERY. FOLLOW-UP INFORMATION, ON 19-SEPT-2007: THERE WAS NO HISTORY OF INFECTION NOTED ON ADMISSION. IT WAS A CLOSED FRACTURE. PRE-OP WBC. POST-OP WBC- NORMAL. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF A FINAL ASSESSMENT.

    Description of Event or Problem · 1

    ADDITIONAL PATIENT INFORMATION: WEIGHT: OBESE (PER CHART). FURTHER DETAILS OF EVENT PROVIDED, INFECTION CONTROL MANAGER FOR THE HOSPITAL. PROCEDURE: MINIMAL INCISION, OPEN REDUCTION INTERNAL FIXATION WITH SYNTHES LOCKING CONDYLAR PLATE AND INSTRUMENTATION OF RIGHT FEMUR. TREATMENT OF ADVERSE EVENT: MEDICATIONS/DOSAGE USED: K-FLEX FOR 2 WEEKS. THERAPIES OR NON-DRUG TREATMENTS USED: WOUND CLEANSED WITH HYDROGEN PEROXIDE AND SALINE (CHART REVIEWED BY REPORTER, STATED BY HIS READINGS, FELT THE WOUND WAS SUPERFICIAL). STATUS OF PT: CLINICAL NOTES: WOUND HEALED AND LOOKED FINE, FOLLOW-UP VISIT ON TWO MONTHS LATER - NO MENTION OF INFECTION, NOTED EXCELLENT UNION OF FRACTURE PER X-RAY. WOULD NOT NEED TO SEE PT AGAIN UNLESS THERE WAS A PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOSEAL MATRIX HEMOSTATIC SEALANT LMF - AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASE LMF BAXTER HEALTHCARE CORPORATION 934057 060801

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention