BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-MAX II, SHOULDER EXPOSURE POSITIONER

    MDR report key: 4199396 · Received October 24, 2014

    Report

    Report Number
    1643264-2014-00028
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 29, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    FWZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER INDICATED THAT THERE IS NO PRODUCT/DEVICE TO BE RETURNED FOR INVESTIGATION ANALYSIS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THIS AS A USER ERROR, BECAUSE THE TABLE WAS NOT PROPERLY LOCKED OFF. DURING AN ARTHROSCOPIC SUB-ACROMIAL DECOMPRESSION (ASAD) PROCEDURE USING A T-MAX II, SHOULDER EXPOSURE POSITIONER, IT WAS REPORTED THAT WHEN SETTING THE PATIENT UP ON T-MAX TABLE, THE ATTACHMENT SLIPPED BACK CAUSING THE PATIENT TO FALL BACK, BENDING THE BAR ON THE INTUBATION TREE. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS SENT TO RECOVERY; AT WHICH TIME, THE PATIENT COMPLAINED OF HEAD AND NECK PAIN AND HAD UNKNOWN TESTS ADMINISTERED. THE PATIENT¿S CURRENT CONDITION IS REPORTED AS OKAY AND IS AT HOME GETTING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679830 T-MAX II, SHOULDER EXPOSURE POSITIONER T-MAX II FWZ SMITH & NEPHEW, INC. 7210551

    Patients

    Seq Age Sex Outcome Treatment
    1 Other