BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIDE MOBILITY PRODUCTS

    MDR report key: 3853686 · Received June 6, 2014

    Report

    Report Number
    2530130-2014-00043
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    March 28, 2014
    Report Date
    June 5, 2014
    Manufacturer
    PRIDE MOBILITY PRODUCTS
    Product Code
    ITI
    PMA / PMN Number
    K042612
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER AND DATE OF MANUFACTURE HAVE NOT BEEN PROVIDED. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR EVALUATION AT THIS TIME. SHOULD FURTHER INFORMATION OR THE DEVICE BECOME AVAILABLE, A FOLLOW-UP REPORT WILL THEN BE ISSUED.

    Description of Event or Problem · 1

    THE CLAIMANT WAS RIDING ALONG THE PAVEMENT IN HIS PRIDE Q600 SPORT POWERCHAIR. THE REAR AXLE IN THE POWERCHAIR MALFUNCTIONED CAUSING THE CLAIMANT TO BE THROWN OUT OF CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333121 PRIDE MOBILITY PRODUCTS POWERED WHEELCHAIR ITI PRIDE MOBILITY PRODUCTS Q600 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization