BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIDE

    MDR report key: 1585967 · Received January 21, 2010

    Report

    Report Number
    2530130-2010-00002
    Event Type
    Other
    Date Received
    January 21, 2010
    Date of Event
    November 15, 2009
    Report Date
    January 20, 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. ALTHOUGH IT APPEARS THAT THIS EVENT IS NOT PRODUCT RELATED, A FOLLOW UP REPORT WILL BE SUBMITTED UPON REVIEW OF THE PRODUCT AND COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMERS LEG WENT INTO A SPASM AND HER FOOT BECAME CAUGHT BETWEEN THE FOOTPLATE AND CASTER. THE PROVIDER CONFIRMED THAT THE CUSTOMER WAS NOT DRIVING THE POWERCHAIR, BUT WAS TRANSFERRING WHEN THIS OCCURRED. THE USER SUSTAINED A TENDON TEAR TO THE RIGHT ANKLE WHICH REQUIRED A DOCTOR VISIT AND LEG BOOT. THE CUSTOMER REQUIRES RESTRAINING DEVICES DUE TO HER CONDITION, BUT REFUSES TO WEAR THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIDE POWERCHAIR ITI PRIDE MOBILITY PRODUCTS CORP. Q600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other