BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6MM 30CM HEMASHIELD PLAT WDV

    MDR report key: 3060316 · Received April 11, 2013

    Report

    Report Number
    2242352-2013-00345
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    MAL
    PMA / PMN Number
    K021213
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A PROCEDURE THERE WAS BLEEDING PRESENT ON THE HEMASHIELD GRAFT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156650 6MM 30CM HEMASHIELD PLAT WDV VASCULAR GRAFT MAL MAQUET CARDIOVASCULAR VS02175206P0 25037226

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other