BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARDIK BIOGRAFT

    MDR report key: 40458 · Received September 26, 1996

    Report

    Report Number
    2183620-1996-00002
    Event Type
    Injury
    Date Received
    September 26, 1996
    Report Date
    September 25, 1996
    Manufacturer
    BIO-VASCULAR, INC
    Product Code
    FZC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGISTION INDICATED THAT PHYSICIAN MISINTERPRETEDF THE NORMAL SPIRAL EXTERIOR OF THE VEIN GRAFT AS TWISTING. CO EXPLAINED THIS TO THE DISTRIBUTER FOR RELAY TO THE MD. CO DETERMINEDF THAT THERE WAS NO PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    THE VASCULAR GRAFT TWISTED DURING IMPLANTATION, SO HE EXPLANTED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DARDIK BIOGRAFT PERIPHERAL VASCULAR GRAFT FZC BIO-VASCULAR, INC 404505 1-3J04-3252

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention