BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMBRAGEL

    MDR report key: 2821024 · Received October 25, 2012

    Report

    Report Number
    1222315-2012-00014
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    November 24, 2011
    Report Date
    October 24, 2012
    Manufacturer
    INSTITUT STRAUMANN
    Product Code
    NPK
    PMA / PMN Number
    K101956
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    MEMBRAGEL, CATALOG #070.101 PACKAGE INSERT INSTRUCTIONS FOR USE STATE "TREATMENT OUTCOME IS DEPENDENT ON OPERATIVE TECHNIQUE AND PT RESPONSE. AS WITH ANY SURGICAL PROCEDURE, INFECTION IS A RISK. USE STERILE INTRA-OPERATIVE TECHNIQUE. DO NOT USE AT INFECTED SITES". MEMBRAGEL, CATALOG #070.101 PACKAGE INSERT INSTRUCTIONS FOR USE STATE "THE FOLLOWING COMPLICATIONS ARE COMMON WITH THE SURGICAL INTERVENTION WITH BARRIER MEMBRANES AND THEREFORE MAY NOT BE TOTALLY EXCLUDED: SOFT TISSUE DEHISCENCE, HEMATOMA, PAIN, INFLAMMATION, INCREASED SENSITIVITY AND REDNESS." THE MANUFACTURER CARRIED OUT A REVIEW OF THE BATCH RECORD DOCUMENTATION AND CONFIRMS THAT THE PRODUCT WAS RELEASED ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    CLINICIAN REPORTS THAT HE USED MEMBRAGEL TOGETHER WITH PUROS ALLOGRAFT IN AN AUGMENTATION PROCEDURE. THERE WAS A SEVERE INFLAMMATORY RESPONSE. THE TISSUE LOOKED TERRIBLE UNTIL THE REMOVAL OF THE MEMBRANE. THE CLINICIAN REPORTS THAT THE INFECTED MEMBRANE WAS REMOVED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEMBRAGEL BARRIER MEMBRANE NPK INSTITUT STRAUMANN AW195

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other PUROS ALLOGRAFT