BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EYE STRETCHER CHAIR

    MDR report key: 3171031 · Received June 14, 2013

    Report

    Report Number
    0001831750-2013-05459
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSPECTION IDENTIFIED THAT THE PLASTIC AROUND THE ARM PAD WAS CRACKED AND ALLEGEDLY EXPOSING SHARP EDGES.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDE RAIL WAS BROKEN EXPOSING SHARP EDGES. MANUFACTURER'S INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT MAY BE SUBMITTED.NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDE RAIL WAS BROKEN EXPOSING SHARP EDGES. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270706 EYE STRETCHER CHAIR STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1