BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURA-GUARD

    MDR report key: 335477 · Received May 29, 2001

    Report

    Report Number
    2183620-2001-00009
    Event Type
    Other
    Date Received
    May 29, 2001
    Report Date
    April 24, 2001
    Manufacturer
    BIO-VASCULAR
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTED THAT ABOUT 1 YEAR AGO HE HAD A PT WITH A DURA-GUARD IMPLANT THAT DEVELOPED AN INFECTION. NO INFO WAS GIVEN BY SURGEON FOR PT IDENTIFICATIONS, DATE OF IMPLANT, EXPLANT STATUS, CULTURE IDENTIFICATION, OTHER INTERVENTIONS, OR PT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24814 DURA-GUARD DURAL REPAIR PATCH DSY BIO-VASCULAR UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other