BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIDE

    MDR report key: 1631486 · Received March 12, 2010

    Report

    Report Number
    2530130-2010-00018
    Event Type
    Other
    Date Received
    March 12, 2010
    Date of Event
    February 15, 2010
    Report Date
    March 2, 2010
    Manufacturer
    PRIDE MOBILITY PRODUCTS CORP.
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - NOT A PRODUCT PROBLEM, MDR REPORTED DUE TO INJURY; RESULTS - USER ERROR.

    Description of Event or Problem · 1

    THE END USER'S DAUGHTER ALLEGES, HER MOTHER WAS IN BED MOVING A COMFORTER THAT WAS PARTIALLY ON THE POWERCHAIR, WHEN SHE GOT THE COMFORTER CAUGHT ON THE CONTROLLER PUTTING THE POWERCHAIR IN MOTION. THE USER GOT HER FOOT TANGLED IN THE COMFORTER; THE USER SUSTAINED A CUT ON THE HEEL OF HER FOOT REQUIRING HOSPITALIZATION FOR TWO DAYS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization