BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIDE

    MDR report key: 1613090 · Received February 19, 2010

    Report

    Report Number
    2530130-2010-00005
    Event Type
    Other
    Date Received
    February 19, 2010
    Date of Event
    December 19, 2009
    Report Date
    February 3, 2010
    Manufacturer
    PRIDE MOBILITY PRODUCTS CORP.
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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

    CUSTOMER ALLEGES, SHE CUT HER ANKLE ON THE POWERCHAIR FOOT PLATE; THE USER SUSTAINED A CUT REQUIRING STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIDE POWERCHAIR ITI PRIDE MOBILITY PRODUCTS CORP. Q614HD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention