BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMBRAGEL

    MDR report key: 1732816 · Received June 21, 2010

    Report

    Report Number
    1222315-2010-00007
    Event Type
    Injury
    Date Received
    June 21, 2010
    Date of Event
    April 3, 2010
    Report Date
    June 21, 2010
    Manufacturer
    BIORA AB
    Product Code
    NPK
    PMA / PMN Number
    K082111
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMPLETED A REVIEW OF THE MANUFACTURING RECORDS AND FOUND THE PRODUCT TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    CLINICIAN REPORTS THAT HE TREATED PT WITH MEMBRAGEL OVER STRAUMANN ALLOGRAFT, AROUND AN IMPLANT. THE TISSUE FACIAL TO THE GRAFT WAS INFLAMED AT ONE WEEK AND AT 2 WEEKS WAS ABSCESSED/INFECTED. HE STATED HE PUSHED ON THE TISSUE FACIAL TO THE IMPLANT AND THE MEMBRAGEL EXFOLIATED OUT THROUGH THE SULCUS. HE SAW HER AT 3 WEEKS AND SHE WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEMBRAGEL BARRIER MEMBRANE NPK BIORA AB MEM913

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention IMPLANT.| USED ALLOGRAFT MATERIAL AND PLACED A DENTAL| AT THE TIME OF MEMBRAGEL USAGE, THE CLINICIAN ALSO