BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RULTRACT SKYHOOK RETRACTOR

    MDR report key: 3663285 · Received December 20, 2013

    Report

    Report Number
    1519227-2013-00001
    Event Type
    Malfunction
    Date Received
    December 20, 2013
    Date of Event
    November 21, 2013
    Report Date
    December 20, 2013
    Manufacturer
    PEMCO, INC.
    Product Code
    GAD
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GIVEN THE INFO RECEIVED FROM THE HOSPITAL PEMCO AGREES WITH THE INITIAL REPORTER THAT IT WAS USE ERROR, AND BELIEVES THAT THE SPOOL CAP NUT WAS NOT PROPERLY TIGHTENED (AS IS STATED IN OUR IFU) WHEN EVENT OCCURRED. THE DEVICE WORKED ACCORDING THE MFR SPECS WHEN IT WAS EVAL AT PEMCO. WE BELIEVE THAT BECAUSE THE SPOOL CAP NUT WAS NOT PROPERLY TIGHTENED THAT THE CABLE WAS ABLE TO GO OVER THE LIP OF THE SPOOL. IF PROPERLY TIGHTENED THIS WILL NOT HAPPEN. AFTER SEVERAL ATTEMPTS TO GET MORE INFO FROM THE HOSPITAL REGARDING THE EVENT, WE DO NOT KNOW IF THERE WAS ANY PT INVOLVEMENT.

    Description of Event or Problem · 1

    A REPRESENTATIVE FROM THE HOSPITAL CONTACT PEMCO STATING THAT THE "CABLE WOUND AROUND THE OUTSIDE OF THAT DRUM, FOR SOME REASON" SHE WAS ALSO TOLD THAT THE CABLE "LET GO" SHE ALSO BELIEVES IT WAS USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670644 RULTRACT SKYHOOK RETRACTOR RETRACTOR GAD PEMCO, INC. 4100-IMR-6

    Patients

    Seq Age Sex Outcome Treatment
    1