BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO MED HEADHOLDER

    MDR report key: 1670344 · Received April 21, 2010

    Report

    Report Number
    1670344
    Event Type
    Malfunction
    Date Received
    April 21, 2010
    Date of Event
    April 16, 2010
    Report Date
    April 21, 2010
    Manufacturer
    PRO MED INSTRUMENTS, INC.
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DR. (B) (6) HAD PINNED THE PT FOR A PRONE POSITION WITH THE MRI SAFE HEAD HOLDER AND LOCKED THE HEAD HOLDER. HEAD HOLDER WAS TESTED BY DR. (B) (6) AND MRI TECH (B) (6). PT'S HEAD'S THEN SLIPPED AFTER SECURED IN PRONE POSITION FROM THE HEAD HOLDER CAUSING A 2.5CM LONG LACERATION ON THE LEFT SIDE ON HIS HEAD. LACERATION CLEANED WITH BETADINE, STAPLED AND ANTIBIOTIC OINTMENT APPLIED BY DR. (B) (6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO MED HEADHOLDER MAYFIELD HBL PRO MED INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR