BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMBRGEL

    MDR report key: 1880290 · Received October 19, 2010

    Report

    Report Number
    1222315-2010-00014
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    July 21, 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
    VA, 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

    PT UNDERWENT A DENTAL TREATMENT ON (B)(6), 2010 WHERE MEMBRAGEL WAS USED. THE CLINICIAN REPORTS ON (B)(6), 2010 THAT PT PRESENTS WITH INFECTED AREAS 18 AND 19 WITH PAIN AND SWELLING. BAKING SODA RINSES, ANTIBIOTICS, PAIN MEDICATION, RINSE WITH PERIDEX ARE PRESCRIBED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention PREMIEN