BEUDAMED
    FDA Adverse Event Summary report: N

    RULTRACT SKYHOOK SURGICAL RETRACTOR SYSTEMS

    MDR report key: 5200557 · Received October 26, 2015

    Report

    Report Number
    1519227-2015-00002
    Date Received
    October 26, 2015
    Date of Event
    September 30, 2015
    Report Date
    October 23, 2015
    Manufacturer
    PEMCO, INC.
    Product Code
    GAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PEMCO RECEIVED DEVICE ON (B)(6) 2015 WITH ONE RAKE CLAMP NOT COMPLETELY TIGHTENED. PER (B)(6), ALL PIECES OF THE DEVICE ARE FUNCTIONING PROPERLY WHEN ASSEMBLED CORRECTLY. WE SUSPECT THE ROOT CAUSE WAS USE ERROR.

    Description of Event or Problem · 1

    A REPRESENTATIVE FOR (B)(6) MEDICAL CENTER CONTACTED PEMCO AND STATED THAT THE RAKES FELL INTO THE CHEST OF A PATIENT AND THE DOCTOR WAS ABLE TO RETRIEVE THEM WITH NO DAMAGE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709780 RULTRACT SKYHOOK SURGICAL RETRACTOR SYSTEMS RATCHET ASSEMBLY W/SNAP CLIP GAD PEMCO, INC. IR4100-IMR6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention