BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL HEMOSTATIC MATRIX

    MDR report key: 2074196 · Received May 2, 2011

    Report

    Report Number
    2954761-2011-00029
    Event Type
    Injury
    Date Received
    May 2, 2011
    Report Date
    April 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    LMF
    PMA / PMN Number
    P990009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE PRODUCT INSTRUCTIONS FOR USE WITH EMPHASIS ON THE CORRECT FLOSEAL APPLICATION STEPS AND THE NEED FOR ALWAYS IRRIGATING EXCESS PRODUCT HAS BEEN PERFORMED WITH THE OPERATING SURGEON. NO FURTHER ACTION IS REQUIRED. THIS CASE WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: ADHESIONS FORM UP TO 90% AND MORE AFTER SURGERY. THIS MAY HAVE MULTIPLE CAUSES. A CAUSALITY ASSESSMENT IS NOT POSSIBLE WITHOUT KNOWING MORE CLINICAL AND PRODUCT APPLICATION DETAILS. (B)(6). AS NO ADDITIONAL CASE DETAILS ARE CURRENTLY AVAILABLE, THIS CASE IS BEING CONSERVATIVELY REPORTED. BAXTER IS CURRENTLY FOLLOWING UP WITH THE SURGEON FOR ADDITIONAL CASE DETAILS. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER FOLLOW-UP MEDICAL ASSESSMENT: ISOLATED POST MARKETING SURVEILLANCE REPORTS AND SOME LITERATURE CASES HAVE SUGGESTED THAT NON-IRRIGATION OF EXCESS FLOSEAL (PRODUCT NOT REACTED WITH THE BLOOD CLOT) MAY CONTRIBUTE, ALONG WITH OTHER SURGERY AND PATHOLOGY RELATED RISK FACTORS, TO ADHESION FORMATION. THIS IS WHY THE INSTRUCTIONS FOR USE OF FLOSEAL EMPHASIZE THE IMPERATIVE OF ALWAYS IRRIGATING THE EXCESS PRODUCT. IN THIS SPECIFIC REPORT, THIS HAS NOT BEEN THE CASE. SINCE THIS USER ERROR MAY BE REPETITIVE, A REVIEW OF THE IFU WITH THE REPORTER WITH SPECIAL FOCUS ON THE CORRECT FLOSEAL APPLICATION STEPS AND THE NEED FOR ALWAYS IRRIGATING EXCESS PRODUCT IS RECOMMENDED. (B)(4). BAXTER IS CURRENTLY ATTEMPTING TO COORDINATE A REVIEW OF THE PRODUCT INSTRUCTIONS FOR USE (IFU) WITH THE SURGEON. A FOLLOW-UP REPORT WILL BE COMPLETED AFTER THIS TASK HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE BAXTER SALES REP STATED THAT THE SURGEON HAD PREVIOUSLY USED FLOSEAL IN A SURGERY A FEW MONTHS BACK. A RE-OPERATION WAS PERFORMED ON THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION RECEIVED BY BAXTER SALES REP ON (B)(4) 2011. THE SURGEON REPORTED THAT ADHESIONS WERE FOUND DURING THE REOPERATION. THE SURGEON DID NOT BELIEVE THAT FLOSEAL CAUSED THE ADHESIONS. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. BAXTER IS CURRENTLY FOLLOWING UP WITH THE SURGEON FOR ADDITIONAL CASE DETAILS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 03-MAY-2011: THE PATIENT WAS A (B)(6) FEMALE WHO WENT IN FOR ABDOMINAL HYSTERECTOMY IN EARLY (B)(6). FLOSEAL WAS APPLIED MIDLINE AND LATERALLY WITH NO IRRIGATION. SHE CAME BACK IN EARLY (B)(6) WITH A CT THAT SUGGESTED ABSCESS. HER VAGINAL VAULT HAD BEEN OPENED AND HAD A TUBE COMING THROUGH. WHEN OPENED FOR RE-OPERATION, ADHESIONS WERE FOUND ALONG WITH OVARIAN CYST, BUT NO ABSCESSES WERE OBSERVED. THE LEFT OVARY AS WELL AS ALL ADHESIONS WERE REMOVED, AND THE VAGINA WAS SOWED. NO ADDITIONAL INFORMATION IS AVAILABLE. (B)(6).

    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 22 YR