BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD RADIOLUCENT SYSTEM

    MDR report key: 535120 · Received March 22, 2004

    Report

    Report Number
    1525725-2004-00010
    Event Type
    Other
    Date Received
    March 22, 2004
    Report Date
    February 23, 2004
    Manufacturer
    SCHAERER MAYFIELD USA, INC.
    Product Code
    HBL
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS OF 03/2004, THE ONLY INFORMATION MADE AVAILABLE TO SCHAERER MAYFIELD USA, INC. IS RECORDED AS FOLLOWS: IN 02/2004, FACILITY REPORTED THE UNIT SLIPPED AND SHIFTED DURING CASE. AT THIS TIME, THERE WAS NO MENTION OF A PT INJURY, AFTER REPEATED ATTEMPTS BY SCHAERER MAYFIELD TO REVIEW THE INCIDENT, SCHAERER MAYFIELD USA, INC. OBTAINED INFORMATION IN 02/2004 FROM THE BUSINESS MGR OF THE PERI-OPERATIVE OR THAT THERE HAD BEEN A REPORTED SCALP LACERATION REGARDING THE ABOVE MENTIONED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD RADIOLUCENT SYSTEM CRANIAL SUPPORT SYSTEM HBL SCHAERER MAYFIELD USA, INC. 40A2004 959

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other