BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOWEL CLAMP

    MDR report key: 6189079 · Received December 20, 2016

    Report

    Report Number
    6189079
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    October 6, 2016
    Report Date
    October 19, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GDJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE IN USE, ONE OF THE TEETH OF A PENETRATING TOWEL CLAMP BROKE OFF AND FLEW ACROSS THE ROOM. THE CLAMP'S 2 PIECES WERE COLLECTED AND INSPECTED TO SEE THAT ALL PIECES WERE ACCOUNTED FOR AND THEY APPEARED TO BE SO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839181 TOWEL CLAMP INSTRUMENT, MANUAL, SURGICAL, GENERAL USE GDJ CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR