BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RULTRACT SKYHOOK RETRACTOR

    MDR report key: 474943 · Received July 30, 2003

    Report

    Report Number
    1519227-2003-00003
    Event Type
    Malfunction
    Date Received
    July 30, 2003
    Date of Event
    May 29, 2003
    Report Date
    June 2, 2003
    Manufacturer
    PEMCO, INC.
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS WAS HOSPITAL REPORTED THAT, DURING DEVICE SET UP, THE FACE PLATE FELL BECAUSE THE CABLE THAT SUPPORTS THE FACE PLATE ASSEMBLY WAS "FOAMED AT THE TIP WHOLE" IT IS TO BE SECURED FOR A SET SCREW. THERE WAS REPORTEDLY NO PT INVOLVEMENT, AND NO ADDITIONAL INFO WILL BE MADE AVAILABLE TO THE MFR. THEREFORE, THIS REPORT IS CONSIDERED COMPLETED AND NO FOLLOW-UP REPORT IS ANTICIPATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN