BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSDUCER COVER

    MDR report key: 9451065 · Received December 10, 2019

    Report

    Report Number
    MW5091562
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    December 6, 2019
    Report Date
    December 6, 2019
    Manufacturer
    CIVCO MEDICAL INSTRUMENTS CO. INC.
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT IN SURGERY FOR RIGHT LOCALIZED PARTIAL MASTECTOMY. A CIVCO CIV-FLEX TRANSDUCER COVER WAS IN USE. TWO ORANGE COLORED ELASTIC BANDS ON COVER BROKE INTRAOPERATIVELY. ALL PIECES RECOVERED. NO PATIENT HARM. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241331 TRANSDUCER COVER TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX CIVCO MEDICAL INSTRUMENTS CO. INC. A086368

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR