BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TBL PACKAGE, TABLE WITH 5TH WHEEL IN CRATE

    MDR report key: 1581935 · Received January 11, 2010

    Report

    Report Number
    2031963-2010-00005
    Event Type
    Injury
    Date Received
    January 11, 2010
    Date of Event
    December 15, 2009
    Report Date
    December 15, 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
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    USER HAD BOTH THUMBS 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 IN MDR 2031963-2009-00003. EVAL SUMMARY: TABLE HEADREST DESIGN SEEMS TO RESULT IN A PINCHPOINT BETWEEN THE PIVOT LEVER AND THE TABLE TOP. THE INCIDENT WAS A RESULT OF AN UNFORESEEN EVENT OF HAVING THE END USER PLACE THEIR THUMBS BETWEEN THE TABLE TOP AND THE PIVOT LEVER. THIS IS NOT A SINGLE-USE DEVICE.

    Description of Event or Problem · 1

    PER THE INITIAL REPORTER, THE SCRUB TECH ALLEGEDLY PINCHED BOTH OF HER THUMBS IN THE TABLE HEADREST. IT WAS REPORTED THAT THE SCRUB TECH WAS GRABBING THE HEADREST (NOT ATTACHED TO THE BED) AND WHILE HOLDING IT, SHE PRESSED THE RELEASE BAR AND HER THUMBS GOT CAUGHT IN BETWEEN THE CYLINDERS AND THE BOARD PIECE. ACCORDING TO THE INITIAL REPORTER, SHE WAS RELEASED OUT BY A CO-WORKER AND THE USER HAD SWOLLEN THUMBS FOR A COUPLE OF DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TBL PACKAGE, TABLE WITH 5TH WHEEL IN CRATE FQO STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other