BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-MAX II SHOULDER EXPOSURE POSITIONER

    MDR report key: 4991404 · Received August 11, 2015

    Report

    Report Number
    1643264-2015-00096
    Event Type
    Injury
    Date Received
    August 11, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 13, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    FWZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT MADE AVAILABLE TO THE DESIGNATED COMPLAINT UNIT FOR EVALUATION AND THUS A VISUAL AND FUNCTIONAL INVESTIGATION COULD NOT BE PERFORMED. NO ACTIONS WERE REQUESTED BY THE CUSTOMER. A REVIEW OF COMPLAINT DATA OVER THE LAST THREE YEARS DID NOT FIND ANY SIMILAR REPORTS OF CAUSING NEURALGIA TO PATIENTS IT WAS IDENTIFIED THAT THE PATIENT MAY HAVE CONSTITUTIONAL BIAS TOWARDS THIS CONDITION BASED ON THE MEDICAL HISTORY OF A TRANSIENT EPISODE OCCURRING 20 YEARS PRIOR. THE COMPLAINT WILL BE CLOSED WITHOUT FURTHER ACTION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING AN ARTHROSCOPIC SUB-ACROMIAL DECOMPRESSION PROCEDURE, IT WAS REPORTED THAT THE PATIENT SUFFERED NEURALGIA ON THE UNDERSIDE OF THEIR THIGH FOLLOWING USE OF THE TMAX. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD BEEN POSITIONED FOR 35 MINUTES IN THE TMAX. THE PATIENT DID NOT MOVE. NO NEUROVASCULAR CHECKS WERE PERFORMED ON THE EFFECTED EXTREMITY DURING THE PROCEDURE. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. THE PATIENT IS STILL NUMB. THE PATIENT DID HAVE A TRANSIENT EPISODE 20 YEARS AGO, SO SHE MAY HAVE A CONSTITUTIONAL BIAS TOWARDS THIS CONDITION..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527630 T-MAX II SHOULDER EXPOSURE POSITIONER ACCESSORIES, OPERATING-ROOM, TABLE FWZ SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other