BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIDE

    MDR report key: 1810738 · Received August 12, 2010

    Report

    Report Number
    2530130-2010-00044
    Event Type
    Other
    Date Received
    August 12, 2010
    Date of Event
    July 11, 2010
    Report Date
    August 3, 2010
    Manufacturer
    PRIDE MOBILITY PRODUCTS CORPORATION
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEG RESTS FROM THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WERE EVALUATED.(B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT THE PATIENT WAS IN AN INVACARE MANUAL WHEELCHAIR EQUIPPED WITH COMPATIBLE PRIDE LEG RESTS. THE PATIENT ALLEGEDLY SUSTAINED A CUT ON HER LEG FROM THE LEG REST, REQUIRING STITCHES AT THE EMERGENCY ROOM.

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT THE PATIENT WAS IN AN INVACARE MANUAL WHEELCHAIR EQUIPPED WITH COMPATIBLE PRIDE LEG RESTS. THE PATIENT ALLEGEDLY SUSTAINED A CUT ON HER LEG FROM THE LEG REST, REQUIRING STITCHES AT THE EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIDE LEG REST IOR PRIDE MOBILITY PRODUCTS CORPORATION NA-LEG REST ONLY NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization