BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMBRAGEL

    MDR report key: 1880272 · Received October 19, 2010

    Report

    Report Number
    1222315-2010-00016
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 30, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BIORA AB
    Product Code
    NPK
    PMA / PMN Number
    K082111
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    MFR COMPLETED A REVIEW OF THE MFG RECORDS AND FOUND THE PRODUCT TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    CLINICIAN REPORTS THAT A DENTAL TREATMENT FOR AN APICAL FENESTRATION WAS CARRIED ON (B)(6)2010 WHERE MEMBRAGEL WAS USED. EIGHT WEEKS LATER, THE PT PRESENTED WITH SWELLING AND REDDENING IN BUCCAL WITH VERITABLE PAIN ADJACENT TO GRAFTED SITE. THE CLINICIAN REPORTS AN INFECTION WITH PAIN AND SWELLING. THREE UNSCHEDULED VISITS MADE. KEFLEX 500G AND AUGMENTIN WERE ADMINISTERED. MEMBRAGEL AND IMPLANT STILL STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEMBRAGEL BARRIER MEMBRANE NPK BIORA AB MEM031

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention ALLOGRAFT WITH TETRACYDINE