BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RULTRACT SEYHOOK RETRACTOR

    MDR report key: 473441 · Received July 22, 2003

    Report

    Report Number
    1519227-2003-00002
    Event Type
    Malfunction
    Date Received
    July 22, 2003
    Date of Event
    May 7, 2003
    Report Date
    May 7, 2003
    Manufacturer
    PEMCO, INC.
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE STAFF AT THIS USER FACILITY REPORTED THAT THIS DEVICE WAS BEING USED IN SURGERY WHEN 1 OF THE 2 RAKES FELL FROM THE RAKE PLATE. THE HOSP STAFF ACKNOWLEDGED THAT THEY FAILED TO PROPERLY TIGHTEN THE FASTENING SCRENS THAT ASSEMBLE THE RAKE PLATE CLAMP TO THE RAKE PLATE AND HOLD THE RAKES IN PLACE. THE PT SUSTAINED NO INJURY. THIS REPORT IS CONSIDERED COMPLETE AND NO FOLLOW-UP REPORT IS ANTICIPATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN