BEUDAMED
    FDA Adverse Event Summary report: N

    DORO

    MDR report key: 7850084 · Received September 6, 2018

    Report

    Report Number
    7850084
    Date Received
    September 6, 2018
    Date of Event
    July 12, 2018
    Report Date
    August 31, 2018
    Manufacturer
    PRO-MED INSTRUMENTS, INC.
    Product Code
    HBL
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS POSITIONED IN HEAD PINS, PRONE. SURGICAL RESIDENT MOVED HEAD TO PROVIDE MORE EXTENSION. PATIENT'S HEAD FLEXED AND THE HEAD PINS MOVED. THE PATIENT SUSTAINED A LACERATION TO THE LEFT SIDE OF HER HEAD WITH BLEEDING. THE PATIENT WAS FLIPPED BACK TO SUPINE IMMEDIATELY. ANOTHER SURGICAL ATTENDING ARRIVED IN THE ROOM AND ASSESSED THE PATIENT'S HEAD SUGGESTING THE PATIENT HAD A FRACTURED SKULL. CASE WAS ABORTED AND THE PATIENT WAS SENT TO CT SCAN. THE PATIENT REMAINED PARALYZED THE ENTIRE TIME, AND REMAINED INTUBATED. ANESTHESIA ACCOMPANIED THE PATIENT TO CT SCAN PROVIDING ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694907 DORO HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) HBL PRO-MED INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 22995 DA