BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18MM 30CM HEMASHIELD PLAT WDV

    MDR report key: 3050369 · Received April 8, 2013

    Report

    Report Number
    2242352-2013-00313
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    MAL
    PMA / PMN Number
    K021213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVAL. 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 HOSP REPORTED PRIOR TO IMPLANTING A HEMASHIELD GRAFT, IT WAS OBSERVED THAT THE COLORATION OF THE GRAFT WAS UNUSUAL. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS. THE HOSP INTENDS TO RETURN THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144392 18MM 30CM HEMASHIELD PLAT WDV VASCULAR GRAFT MAL MAQUET CARDIOVASCULAR, LLC VS02175418P0 11934847

    Patients

    Seq Age Sex Outcome Treatment
    1 NA