BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFF SET DOUBLE CLAMP BAR

    MDR report key: 380736 · Received March 5, 2002

    Report

    Report Number
    1035617-2002-00001
    Event Type
    Malfunction
    Date Received
    March 5, 2002
    Date of Event
    December 19, 2001
    Report Date
    February 4, 2002
    Manufacturer
    ZIMMER ORTHO SURGICAL PRODUCTS
    Product Code
    HSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS IN BED, 2 STAFF MEMBERS PRESENT. PT WAS RECEIVING ASSISTANCE TO GET OUT OF BED THE PT HAD BILATERAL KNEE REPLACEMENTS. THE OVERBED TRAPEZE BAR ALLEGEDLY BROKE AT THE CONNECTION SITE AT THE STEEL CONNECTOR. 2 STAFF MEMBERS CAUGHT THE BAR AND THE PT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OFF SET DOUBLE CLAMP BAR TRACTION ACCESSORY HSQ ZIMMER ORTHO SURGICAL PRODUCTS * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention