BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 7103030 · Received December 10, 2017

    Report

    Report Number
    2210968-2017-71694
    Event Type
    Injury
    Date Received
    December 10, 2017
    Report Date
    November 27, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    LMF
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST OPERATIVE SYMPTOMS DESCRIBED IN THE ARTICLE? CITATION: J MED ECON 2015; 18:474¿81 WWW.INFORMAHEALTHCARE.COM/JME.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THE PATIENT UNDERWENT BRAIN/ CEREBRAL (BC), CARDIOVASCULAR (CV: VALVE SURGERY AND CORONARY ARTERY BYPASS GRAFT) OR CAROTID ENDARTERECTOMY (CEA) BETWEEN JANUARY 2011¿DECEMBER 2012. DURING THE PROCEDURE, ABSORBABLE HEMOSTAT WAS USED FOR BLEEDING. AFTER PROPENSITY SCORE MATCHING, UTILIZATION OF ABSORBABLE HEMOSTATS WAS ASSOCIATED WITH A 14¿16% REDUCTION IN MEAN LOS FOR ALL THREE PROCEDURES. IN ALL THREE PROCEDURES, UTILIZATION OF ABSORBABLE HEMOSTATS WAS ASSOCIATED WITH STATISTICALLY SIGNIFICANT LOWER MEAN ALL CAUSE COSTS COMPARED TO SO, WITH THE LOWER MEAN COSTS RANGING FROM 12% FOR CEA TO 18% FOR BC. POST PROCEDURE, THE PATIENT POSSIBLY UNDERWENT BLOOD TRANSFUSION. THE MEAN TRANSFUSED BLOOD PRODUCT COST PER DISCHARGE WAS 38% LOWER FOR ONE GROUP COMPARED TO THE OTHER GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881985 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN HEMOSTATIC AGENT, ABSORBABLE LMF ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1