BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASIC CONFIGURATION MODEL 6100 KNEE GATCH

    MDR report key: 1972314 · Received December 30, 2010

    Report

    Report Number
    1831750-2010-05402
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    STRYKER CORP., MED DIV
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    MR. (B)(6) CALLED OUT CUSTOMER SERVICE, (B)(6), AND REPORTED VIA PHONE THAT THE CYLINDER GIVES AWAY WITH PTS ABOVE 90 KG. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASIC CONFIGURATION MODEL 6100 KNEE GATCH STRETCHER, WHEELED FPO STRYKER CORP., MED DIV 6100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1