BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-MAX EXPOSURE SHOULDER POSITIONER

    MDR report key: 6105454 · Received November 16, 2016

    Report

    Report Number
    1643264-2016-00238
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    October 31, 2016
    Report Date
    May 10, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    FWZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVALUATION CONDUCTED DUE TO THIS DEVICE NOT BEING AVAILABLE FOR RETURN.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE, A T-MAX EXPOSURE SHOULDER POSITIONER, PART NUMBER 7210551, WAS NOT MADE AVAILABLE TO THE DESIGNATED COMPLAINT UNIT FOR EVALUATION AND THUS A VISUAL AND FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE LOT OR SERIAL NUMBER IDENTIFICATION INFORMATION OF THE DEVICE WAS NOT PROVIDED. THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED WITH CONFIDENCE. THE INSTRUCTIONS FOR USE, PART NUMBER 29-99-01, PROVIDED WITH THE DEVICE CONTAIN THE FOLLOWING WARNINGS AND PRECAUTIONARY MEASURES RELATED TO PROPER USE OF THE DEVICE, INCLUDING, BUT NOT LIMITED TO: POSSIBLE COMPLICATIONS SUCH AS PRESSURE ALOPECIA (HAIR LOSS) CAN OCCUR FROM PROLONGED SURGICAL PROCEDURES. PLEASE TAKE APPROPRIATE ACTIONS IF PROLONGED PROCEDURES OCCUR SUCH AS PERIODICALLY REPOSITIONING THE PATIENT¿S HEAD THROUGHOUT THE PROCEDURE; DO NOT OVER TIGHTEN STRAPS HOLDING CHIN IN PLACE AND ENSURE THERE IS NO PRESSURE ON STRUCTURES UNDER THE CHIN; WHEN THE PATIENT IS LOWERED, THE HEAD WILL SLIDE DOWN THE HEADSET PAD; THE FACE MASK MUST BE RELEASED WHEN THE PATIENT IS RAISED OR LOWERED; ENSURE THE FACE MASK¿S CHIN PORTION IS NOT BELOW THE PATIENT¿S CHIN AND DOES NOT CONTACT THE NECK AREA; AND ENSURE FACE MASK IS NOT APPLYING PRESSURE ON THE PATIENT¿S EYES AND PRESSURE ON THE FACE IS EVENLY DISTRIBUTED. THIS EVENT IS DEEMED TO BE ISOLATED AND NO CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. SHOULD THE DEVICE BE RETURNED IN THE FUTURE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED DERMAL DAMAGE TO THE BACK OF THE HEAD AND COMPLAINED OF MILD NUMBNESS AROUND THE JAW WHICH WAS CONFIRMED THE DAY AFTER THE PROCEDURE WHICH UTILIZED THE T-MAX SHOULDER POSITIONER AND FACE MASK. THE DERMAL DAMAGED WAS DESCRIBED AS A REDNESS TO THE SKIN AND WHAT SEEMED TO BE A GRAZE AND HAIR LOSS. THE PATIENT WAS IN THE POSITIONER WITH FACE MASK ON FOR APPROXIMATELY FIVE HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757200 T-MAX EXPOSURE SHOULDER POSITIONER ACCESSORIES, OPERATING-ROOM, TABLE FWZ SMITH & NEPHEW, INC. 7210551

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention