BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL HEMOSTATIC MATRIX

    MDR report key: 3801016 · Received May 8, 2014

    Report

    Report Number
    2032282-2014-00069
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    LMF
    PMA / PMN Number
    P990009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: POSTOPERATIVE INFECTION IS A RARE, BUT YET EXPECTED COMPLICATION AFTER SURGICAL PROCEDURES. GIVEN THE LIMITED CLINICAL INFORMATION (MENTION OF ADVERSE EVENT IN A CLINICAL PUBLICATION), AND THE INABILITY FOR FURTHER CLINICAL INVESTIGATION, WE CANNOT EXCLUDE THAT FLOSEAL HAS CONTRIBUTED TO THE REPORTED POSTOPERATIVE COMPLICATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND COMPLETION OF THE MANUFACTURER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CASE INFORMATION WAS RECEIVED ON (B)(4) 2014 AND THE CASE WAS RE-ASSESSED BY BAXTER'S MEDICAL DIRECTOR. BAXTER FINAL MEDICAL ASSESSMENT: BASED ON THE ADDITIONAL CLINICAL INFORMATION RECEIVED THE REPORTED INFECTION HAS BEEN DETECTED DURING THE SURGICAL PROCEDURE AND BEFORE THE APPLICATION OF FLOSEAL. THEREFORE, THE REPORTED POSTOPERATIVE INFECTION IS NOT RELATED TO THE USE OF FLOSEAL. AS THE CASE WAS DETERMINED TO BE NOT RELATED TO THE USE OF FLOSEAL, NO FURTHER ACTION IS NECESSARY. THIS CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAYWARD COMPLETED THE INVESTIGATION. SAMPLE EVALUATION AND BATCH REVIEW COULD NOT BE PERFORMED AS NO SAMPLE OR LOT NUMBER WAS PROVIDED. FLOSEAL¿S INSTRUCTIONS FOR USE (IFU) WAS REVIEWED AND IT WAS FOUND TO BE ADEQUATE AND SUFFICIENT. NO TREND WAS IDENTIFIED. PER HAYWARD, NO FURTHER INVESTIGATION IS REQUIRED. THIS CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    (B)(4). BAXTER MEDICAL SCIENCE LIAISON SPOKE WITH DR. (B)(6) RESEARCH COORDINATOR ((B)(6)) AND SHE SAID THAT DR. (B)(6) STATED THAT THE INFECTION THAT SHE ((B)(6)HAD WRITTEN THE FIRST DRAFT THAT WAS PROVIDED TO BAXTER) HAD INCLUDED IN THE DRAFT MANUSCRIPT WAS NOT A PROCEDURE-RELATED INFECTION. APPARENTLY WHEN THEY WERE IN SURGERY AND GOT DOWN TO THE SURGICAL SITE THEY IDENTIFIED WHAT LOOKED TO BE AN INFECTION, THEY CULTURED IT, AND POST OPERATIVELY THE CULTURE CAME BACK POSITIVE. THIS IDENTIFICATION OF A POSSIBLE INFECTION WAS MADE PRIOR TO FLOSEAL HAVING BEEN USED. THEREFORE, HE SAID THAT THIS WAS UNRELATED TO FLOSEAL USE, AS HE SUSPECTED THIS INFECTION TO BE PRESENT PRIOR TO USE, AS HE IDENTIFIED IT DURING SURGERY.

    Description of Event or Problem · 1

    STUDY TITLE: (B)(4). THIS IS AN INVESTIGATOR INITIATED STUDY (IIS) CASE SUPPORTED BY BAXTER. BETWEEN (B)(6) 2009 AND (B)(6) 2011,103 TOTAL SHOULDER REPLACEMENTS WERE PERFORMED BY A SINGLE SURGEON WITH THE USE OF THE HEMOSTATIC AGENT, FLOSEAL. ALL PATIENTS WERE INITIALLY EVALUATED WITH A HISTORY, ACTIVE RANGE OF MOTION (ROM), AND RADIOGRAPHIC MEASUREMENTS INCLUDING ANTERO-POSTERIOR (AP) AND AXILLARY (AX) RADIOGRAPHS. ONE PATIENT DEVELOPED A POST-OPERATIVE INFECTION AND REQUIRED ARTHROSCOPIC DÉBRIDEMENT, DISTAL CLAVICLE RESECTION, AND SUPRASCAPULAR NERVE DECOMPRESSION. NO SAMPLE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277586 FLOSEAL HEMOSTATIC MATRIX AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMF BAXTER HEALTHCARE - HAYWARD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other