BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURA-GUARD

    MDR report key: 335473 · Received May 29, 2001

    Report

    Report Number
    2183620-2001-00008
    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
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PEDIATRIC PT UNDERWENT SURGERY WITH DURA-GUARD IMPLANT. SURGEON STATED THAT PT HAD INFLAMMATORY REACTION/INFECTION. PRODUCT WAS EXPLANTED. NO INFO WAS GIVEN BY SURGEON ABOUT PT IDENTIFICATIONS, DATE OF IMPLANT, DATE OF EXPLANT, OTHER INTERVENTIONS, INFECTION CULTURE, OR PT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24771 DURA-GUARD DURAL REPAIR PATCH DSY BIO-VASCULAR UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Required Intervention