BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER CUB CRIB

    MDR report key: 2010420 · Received March 2, 2011

    Report

    Report Number
    MW5019647
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 2, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FMS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HOSPITALIZED IN PEDIATRIC UNIT WITH EXACERBATION OF ASTHMA. AS REPORTED BY THE PATIENT'S MOTHER, PATIENT HAD GOTTEN HIS LEG CAUGHT IN CRIB RAIL AND INJURED HIS LEG. X-RAY PERFORMED ON (B)(6) 2011 CONFIRMED DISTAL TIBIA/FIBULA FRACTURE. FRACTURE IS UNDISPLACED AND INCOMPLETE. WILL REQUIRE SPLINTING BUT NO OTHER INTERVENTION AT THIS TIME. PATIENT WAS MOVED TO ANOTHER CRIB AND THE ORIGINAL EVALUATED BY TECHNICAL SERVICES PERSONNEL. NO STRUCTURAL OR FUNCTIONAL DEFECTS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER CUB CRIB PEDIATRIC CRIB FMS STRYKER MEDICAL FL19F

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Disability