BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURA-GUARD

    MDR report key: 336640 · Received June 7, 2001

    Report

    Report Number
    2183620-2001-00013
    Event Type
    Other
    Date Received
    June 7, 2001
    Report Date
    May 10, 2001
    Manufacturer
    BIO-VASCULAR
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    2001: DISTRIBUTOR REPORTED THAT A SURGEON HAD IMPLANTED A DURA-GUARD AND WAS NOW REPORTING AN INFECTION. 18 DAYS LATER: DISTRIBUTOR REPORTED THAT DOCTOR WAS WAITING "10" BEFORE PURSUING ANY ACTION AGAINST THE 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
    26356 DURA-GUARD DURAL REPAIR PATCH DSY BIO-VASCULAR UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization