BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMBRAGEL

    MDR report key: 2406185 · Received January 6, 2012

    Report

    Report Number
    1222315-2012-00004
    Event Type
    Injury
    Date Received
    January 6, 2012
    Report Date
    January 6, 2012
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    NPK
    PMA / PMN Number
    K101956
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    CLINICIAN REPORTS A PROBLEM WITH MEMBRAGEL. CLINICIAN TOLD STRAUMANN EMPLOYEE THAT SHE USED MEMBRAGEL AND ABOUT ONE WEEK LATER, THE PT PRESENTED WITH AN INFECTION AND WHAT APPEARED TO BE PUS. ROOT CAUSE UNK. CLINICIAN IS NOT BLAMING MEMBRAGEL AND WILL FOLLOW UP WITH PT IN ABOUT A WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEMBRAGEL PROD CODE NPK - BARRIER MEMBRANE NPK INSTITUT STRAUMANN AG AG318

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention