BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTIER, HEAD REST WARNING KIT

    MDR report key: 1570053 · Received December 23, 2009

    Report

    Report Number
    2031963-2009-00051
    Event Type
    Injury
    Date Received
    December 23, 2009
    Date of Event
    October 15, 2009
    Report Date
    November 24, 2009
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FQO
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1418-2009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    USER HAD FINGER PINCHED IN HEADREST. THIS RESULTED IN ALLEGED BRUISING. THERE IS NO ESTABLISHED EXPIRATION DATE FOR THIS DEVICE. SAID DEVICE WAS NOT EVALUATED. THE MALFUNCTION HAS OCCURRED PREVIOUSLY AND WAS INVESTIGATED. THIS MALFUNCTION HAS BEEN REPORTED PREVIOUSLY IN MDR 2031963-2009-00003. DEVICE MANUFACTURED DATE IS UNKNOWN AT THIS POINT. FURTHER ATTEMPTS WILL BE MADE FOR THIS INFO. EVALUATION SUMMARY: TABLE HEADREST DESIGN SEEMS TO RESULT IN A PINCH POINT BETWEEN THE PIVOT LEVER AND THE TABLE TOP. THE INCIDENT WAS A RESULT OF AN UNFORESEEN EVENT OF HAVING THE END USER PLACE A FINGER BETWEEN THE TABLE TOP AND PIVOT LEVER. THIS IS NOT A SINGLE-USE DEVICE.

    Description of Event or Problem · 1

    PER THE INITIAL REPORTER, THE NURSE ALLEGEDLY PINCHED HER FINGER IN THE HEADREST WHILE ADJUSTING IT. ACCORDING TO THE INITIAL REPORTER, THE USER'S FINGER WAS BRUISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTIER, HEAD REST WARNING KIT FQO STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other