BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKERCUB

    MDR report key: 2130553 · Received June 10, 2011

    Report

    Report Number
    2130553
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 10, 2011
    Manufacturer
    STRYKER
    Product Code
    FMS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    NO PATIENT INVOLVEMENT WITH THIS EVENT. AFTER PATIENT WAS DISCHARGED, HOUSEKEEPER WAS CLEANING AN INFANT CRIB WHEN METAL COATED BARS WERE NOTED TO BE PEELING. PEELINGS VERY SHARP AND DANGEROUS. CRIB TAKEN OUT OF COMMISSION DUE TO SAFETY CONCERNS. MANUFACTURER NOTIFIED. PICTURES TAKEN AND AVAILABLE. SAMPLE SHAVINGS ALSO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKERCUB INFANT CRIB FMS STRYKER FL19H *

    Patients

    Seq Age Sex Outcome Treatment
    1 *