BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSEAL SURGICAL SEALANT

    MDR report key: 3793896 · Received May 6, 2014

    Report

    Report Number
    2032282-2014-00066
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 24, 2014
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    NBE
    PMA / PMN Number
    P030039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE ADDITIONAL PRODUCT INFORMATION HOWEVER NO RESPONSE WAS RECEIVED. DUE TO THE LIMITED INFORMATION, BAXTER HAYWARD COULD NOT PERFORM A SAMPLE EVALUATION OR BATCH REVIEW AS NO SAMPLE OR LOT NUMBER WERE PROVIDED. NO TREND WAS IDENTIFIED. PER HAYWARD, NO FURTHER INVESTIGATION IS REQUIRED. THIS COMPLAINT WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: THE INADVERTENT USE OF AN EXPIRED, BUT CORRECTLY LABELED PRODUCT IS AN ABNORMAL USE, BEYOND THE CONTROL OF THE MANUFACTURER. USE OF AN EXPIRED PRODUCT IMPLIES THAT THE THERAPEUTIC EFFECT AND/OR STERILITY MAY BE IMPACTED AND POTENTIALLY CAUSE HARM. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS ADMINISTERED COSEAL WITH AN EXPIRED DATE OF 08/2013. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270341 COSEAL SURGICAL SEALANT SEALANT, POLYMERIZING NBE BAXTER HEALTHCARE - HAYWARD

    Patients

    Seq Age Sex Outcome Treatment
    1