BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SERIES 29

    MDR report key: 2062613 · Received April 8, 2011

    Report

    Report Number
    1831750-2011-03435
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY CANNOT IDENTIFY THE SPECIFIC UNIT THE INJURY OCCURRED ON AND AS SUCH, CANNOT CONFIRM IF THE REPORTED UNIT IS IN OR OUT OF SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FLEXIBLE JOINT AT THE TOP OF THE SIDERAIL DID NOT HAVE A COVER, AND WHILE THE SIDERAIL WAS BEING PULLED UP DURING CLEANING, THE FEMALE STAFF MEMBER WAS INJURED. IT WAS REPORTED THE STAFF MEMBER'S NAIL BED WAS CUT AND A COMPOUND FRACTURE REQUIRING SURGERY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTAGE SERIES 29 HOSPITAL WHEELED STRETCHER FPO STRYKER MEDICAL 1501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK