BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HFD100 SKULL CLAMP ASSEMBLY

    MDR report key: 3941025 · Received June 19, 2014

    Report

    Report Number
    3003807210-2014-00001
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 15, 2014
    Report Date
    June 18, 2014
    Manufacturer
    IMRIS, INC.
    Product Code
    HBL
    PMA / PMN Number
    K103493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERGOING CRANIAL SURGERY "BUCKED" OR "COUGHED" DURING THE (B)(6) 2014 PROCEDURE, CAUSING HIS HEAD TO SLIP FROM THE HFD100 SKULL CLAMP ASSEMBLY. THE SLIP RESULTED IN A LACERATION TO THE PATIENT'S SCALP, REQUIRING 4 STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360235 HFD100 SKULL CLAMP ASSEMBLY HEAD FIXATION DEVICE/SKULL CLAMP HBL IMRIS, INC. HFD100 113802-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention