BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMMETRY CLASSIC PLUS MAYO-HEGAR NEEDLE HOLDER

    MDR report key: 7534255 · Received May 21, 2018

    Report

    Report Number
    MW5077389
    Event Type
    Injury
    Date Received
    May 21, 2018
    Date of Event
    May 3, 2018
    Report Date
    May 18, 2018
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    FHQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING CESAREAN SECTION PROCEDURE, FRAGMENTS OF THE INNER PLATE OF THE NEEDLE HOLDER BROKE OFF THE DEVICE AND DROPPED INTO OPERATIVE FIELD DURING SURGICAL CLOSURE. THE FRAGMENTS WENT LOCATED AND REMOVED FROM THE PT PRIOR TO CLOSING THE INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372169 SYMMETRY CLASSIC PLUS MAYO-HEGAR NEEDLE HOLDER HOLDER NEEDLE FHQ SYMMETRY SURGICAL INC. 36-2017

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR