BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUPLUG

    MDR report key: 5037801 · Received August 27, 2015

    Report

    Report Number
    3007738819-2015-00012
    Event Type
    Injury
    Date Received
    August 27, 2015
    Report Date
    August 4, 2015
    Manufacturer
    OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY
    Product Code
    LYC
    PMA / PMN Number
    K111087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THE DEVICE (REFERENCED IN THIS REPORT) WAS NOT RETURNED TO OLYMPUS TERUMO BIOMATERIALS CORP. FOR EVALUATION, THE CAUSE OF THE ADVERSE EVENT HAVE NOT BEEN SPECIFIED. TERUPLUG IN THE US IS SOLD UNDER THE NAME "FOUNDATION". THE FOUNDATION PACKAGE INSERT STATES IN THE FOLLOWING SECTION: <PRECAUTIONS FOR USE> THIS PRODUCTS HAS NO ANTIMICROBIAL PROPERTIES. ANY DECISION REGARDING THE USE OF AN ANTIBIOTIC OR OTHER THERAPIES WHEN USING THIS PRODUCT SHOULD BE MADE BASED UPON THE PATIENT'S RISK OF INFECTION. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IS AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE PATIENT HAD UNDERGONE THE EXTRACTION OF A MAXILLARY THIRD MOLAR ABOUT 10 DAYS BEFORE THE PATIENT'S VISIT TO THE OTOLARYNGOLOGIST. DURING THE TOOTH EXTRACTION, THE EXTRACTION SOCKET WAS FILLED WITH ABSORBABLE TOPICAL HEMOSTATIC MATERIAL (HEREAFTER, THIS PRODUCT) BECAUSE OF PERFORATION OF MAXILLARY SINUS MEMBRANE. HOWEVER, SINCE PAIN PERSISTED THEREAFTER, THE PATIENT VISITED THE OTOLARYNGOLOGIST. CLINICAL FINDINGS AND TREATMENT: THE PATIENT WAS SUFFERING FROM MAXILLARY SINUS EMPYEMA. THE OTOLARYNGOLOGIST CARRIED OUT SINUS IRRIGATION FROM THE NASAL CAVITY. NO LEAK OF SOLUTION INTO THE ORAL CAVITY WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569046 TERUPLUG BONE GRAFTING MATERIAL, SYNTHETIC LYC OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention