BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYO CATGUT

    MDR report key: 3549814 · Received December 26, 2013

    Report

    Report Number
    3549814
    Event Type
    Malfunction
    Date Received
    December 26, 2013
    Date of Event
    September 18, 2013
    Report Date
    December 26, 2013
    Manufacturer
    RICHARD-ALLAN MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    AFTER MULTIPLE TRIES, WHILE THE MD WAS SUTURING THE ROTATOR CUFF WITH THIS FREE NEEDLE, THE EYELET OF THE NEEDLE BROKE INTO TWO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675917 MAYO CATGUT NEEDLE, TROCAR GCJ RICHARD-ALLAN MEDICAL 217006 2014-06-11

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR NO OTHER THERAPIES