BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 7046637 · Received November 20, 2017

    Report

    Report Number
    2134070-2017-00075
    Event Type
    Injury
    Date Received
    November 20, 2017
    Date of Event
    October 26, 2017
    Report Date
    November 7, 2017
    Manufacturer
    STERILMED, INC.
    Product Code
    OWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A SUPPLEMENTAL FORM WILL BE SENT ONCE THE EVALUATION IS COMPLETED IF THE DEVICE IS RETURNED. THE DEVICE HISTORY WAS UNABLE TO BE REVIEWED AS NO LOT NOT WAS SUPPLIED BY THE CUSTOMER FOR THIS DEVICE. REPORTER PHONE NUMBER: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AFIB CASE, A PERICARDIAL EFFUSION WAS NOTICED. NO ABLATION WAS PERFORMED PRIOR TO NOTICING THE INJURY. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ICE. CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 1.2 LITERS. IT WAS BELIEVED BY THE STAFF THAT THE PERICARDIAL EFFUSION WAS CAUSED BY HUMAN FACTORS AND THAT THE DEVICE FUNCTIONED AS IT SHOULD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825068 N/A IMAGING CATHETER OWQ STERILMED, INC. R10438577

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other