BEUDAMED
    FDA Adverse Event Summary report: N

    GROSS TRACTION UNIT

    MDR report key: 3589475 · Received January 23, 2014

    Report

    Report Number
    1043572-2014-00007
    Date Received
    January 23, 2014
    Date of Event
    December 30, 2013
    Report Date
    January 23, 2014
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    JEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GROSS TRACTION DEVICE HAS BEEN SENT BACK TO STERIS MONTGOMERY FOR EVALUATION. THE INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE EVALUATION REVEALED ASSEMBLY ERRORS WITHIN THE GROSS TRACTION DEVICE. WHEN THE UNIT WAS REASSEMBLED TO SPECIFICATION, IT WAS FOUND TO FUNCTION NORMALLY AND CORRECTLY. A REVIEW OF ON-HAND INVENTORY WAS CONDUCTED AND REVEALED THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    NO PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THEIR GROSS TRACTION DEVICE DID NOT FUNCTION PROPERLY DURING A PATIENT PROCEDURE. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54323 GROSS TRACTION UNIT TABLE ACCESSORY JEB STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1