BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20X10MM 40CM HEMA MDV BIF

    MDR report key: 3231791 · Received July 15, 2013

    Report

    Report Number
    2242352-2013-00699
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    MAL
    PMA / PMN Number
    K954848
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ABDOMINAL AORTIC ANEURYSM THE COLLAGEN COATING ON THE HEMASHIELD GRAFT APPEARED DISCOLORED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327629 20X10MM 40CM HEMA MDV BIF VASCULAR GRAFT MAL MAQUET CARDIOVASCULAR, LLC VS020852010 25059787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA