BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RULTRACT

    MDR report key: 558341 · Received May 3, 2004

    Report

    Report Number
    1519227-2004-00002
    Event Type
    Malfunction
    Date Received
    May 3, 2004
    Date of Event
    March 19, 2004
    Report Date
    April 30, 2004
    Manufacturer
    PEMCO, INC.
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A PRONG TIP OF THE RETRACTOR RAKE BROKE OFF DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED AND THE TIP PIECE WAS REMOVED BY DR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RULTRACT SURGICAL RETRACTOR GAD PEMCO, INC. 4100-IMR-6 1996

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN