BEUDAMED
    FDA Adverse Event Other Summary report: N

    TERUPLUG

    MDR report key: 4454482 · Received January 19, 2015

    Report

    Report Number
    3007738819-2015-00001
    Event Type
    Other
    Date Received
    January 19, 2015
    Report Date
    December 22, 2014
    Manufacturer
    OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY
    Product Code
    LYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE (REFERENCED IN THIS REPORT) WAS NOT RETURNED TO OLYMPUS TERUMO BIOMATERIALS CORP FOR EVALUATION. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE PT WAS TRANSPORTED TO THIS HOSPITAL BECAUSE OF ANAPHYLACTOID REACTION, SUCH AS FACIAL SWELLING, THAT HAD OCCURRED IN 20-30 MINUTES AFTER THE USE OF THIS PRODUCT (TERUPLUG). THE REACTION, HOWEVER, SUBSIDED SOON WITHOUT ANY TREATMENT. THE IDENTIFICATION OF CAUSATIVE SUBSTANCE IS ONGOING IN THIS HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44055 TERUPLUG LYC OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1