BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOGRAFT

    MDR report key: 340752 · Received July 5, 2001

    Report

    Report Number
    2183620-2001-00015
    Event Type
    Other
    Date Received
    July 5, 2001
    Report Date
    June 8, 2001
    Manufacturer
    BIO-VASCULAR
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTED THAT PT HAD BIOGRAFT IMPLANTED, 2 DAYS POST-OP PT "REJECTED THE BIOGRAFT" AND IT WAS EXPLANTED. NO INFO WAS GIVEN BY SURGEON FOR PT IDENTIFICATIONS, DATE OF IMPLANT, EXPLANT STATUS, OTHER INTERVENTIONS, OR PT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30280 BIOGRAFT MODIFIED HUMAN UMBILICAL VEIN GRAFT DSY BIO-VASCULAR UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other