BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEN MEDICAL SYSTEMS SHOULDER SUPPORT

    MDR report key: 547749 · Received October 8, 2004

    Report

    Report Number
    1221538-2004-00006
    Event Type
    Injury
    Date Received
    October 8, 2004
    Date of Event
    June 7, 2004
    Report Date
    September 8, 2004
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    HOSPITAL ASSOCIATION MALPRACTICE AND GENERAL LIABILITY TRUST IS A THIRD PARTY ADMINISTRATOR FOR THE HOSPITAL WHERE THE PT WAS TREATED. THEY REPORTED THAT THE PT UNDERWENT A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY IN THE TRENDELENBURG POSITION. IMMEDIATELY AFTER THE SURGERY THE PT COMPLAINED OF NUMBNESS AND TINGLING IN THEIR LEFT ARM AND HAND. PT CONTINUES TO BE TREATED BY A NEUROLOGIST AND OCCUPATIONAL THERAPIST. PT IS HAVING SOME PAIN ALONG WITH THE NUMBNESS AND WEAKNESS. PRELIMINARY DIAGNOSIS IS "CERVICAL RADICULOPATHY V. RADIAL NERVE NEUROPATHY." IN ADDITION TO THE MANUFACTURER, THE HOSPITAL, SURGEON, ANESTHESIOLOGIST AND CRNA WERE ALL NOTIFIED OF THIS SITUATION IN AN ATTEMPT TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MEDICAL SYSTEMS SHOULDER SUPPORT PT POSITIONING DEVICE FWZ ALLEN MEDICAL SYSTEMS A-63500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention