BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAGUIDE COLLAGEN DENTAL MEMBRANE

    MDR report key: 2555919 · Received April 27, 2012

    Report

    Report Number
    2530154-2012-00005
    Event Type
    Injury
    Date Received
    April 27, 2012
    Date of Event
    February 1, 2012
    Report Date
    April 27, 2012
    Manufacturer
    KENSEY NASH CORP.
    Product Code
    NPL
    PMA / PMN Number
    K090919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY TWO MONTHS AFTER COLLAGUIDE IMPLANTATION TO COVER BONE GRAFT, A PATIENT DEVELOPED AN INFECTION. NO ADDITIONAL INFORMATION IS AVAILABLE AS OF THE DATE OF THIS INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAGUIDE COLLAGEN DENTAL MEMBRANE NPL KENSEY NASH CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention