BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-MAX EXPOSURE SHOULDER POSITIONER

    MDR report key: 5463542 · Received February 26, 2016

    Report

    Report Number
    1643264-2016-00030
    Event Type
    Injury
    Date Received
    February 26, 2016
    Date of Event
    February 23, 2016
    Report Date
    February 23, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    FWZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION NARRATIVE - THE SUBJECT DEVICE, A T-MAX EXPOSURE SHOULDER POSITIONER, PART NUMBER 7210551 WITH SERIAL NUMBER (B)(4), WAS NOT MADE AVAILABLE TO THE DESIGNATED COMPLAINT UNIT FOR EVALUATION AND THUS A VISUAL AND FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. DETAILS OF BRUISING ON THE LEFT OPERATIVE SIDE OBSERVED POST-OPERATIVELY WERE NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THE DEVICE WAS RELEASED TO DISTRIBUTION ON OR ABOUT NOVEMBER 09, 2012 AND HAS BEEN IN SERVICE FOR APPROXIMATELY THREE YEARS. THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED WITH CONFIDENCE. FACTORS WHICH COULD HAVE CONTRIBUTED TO THIS EVENT INCLUDE PROPER SET UP OF THE POSITIONING SYSTEM, USE OF UNAPPROVED RESTRAINTS AS WELL AS PATIENT FACTORS. PLEASE REFER TO THE INSTRUCTIONS FOR USE PROVIDED WITH THE EQUIPMENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. SHOULD THE DEVICE BE RETURNED IN THE FUTURE, THIS INVESTIGATION WILL BE REOPENED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BRUISING WAS NOTICED TO THE PATIENT POST-OPERATIVELY AFTER UNDERGOING A PROCEDURE THAT UTILIZED THE T-MAX II SHOULDER EXPOSURE POSITIONER. NO PROCEDURAL DELAY WAS NOTED. THERE WAS NO REPORT OF DEVICE MALFUNCTION DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118896 T-MAX EXPOSURE SHOULDER POSITIONER ACCESSORIES, OPERATING-ROOM, TABLE FWZ SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other