BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRIDE MOBILITY PRODUCTS

    MDR report key: 3724702 · Received April 3, 2014

    Report

    Report Number
    2530130-2014-00023
    Event Type
    Death
    Date Received
    April 3, 2014
    Date of Event
    March 26, 2014
    Report Date
    April 2, 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
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER AND DATE OF MANUFACTURE HAVE NOT BEEN PROVIDED. THIS INCIDENT WAS NOT A PRODUCT PROBLEM. SHOULD THE DEVICE OR FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL THEN BE ISSUED. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    REPORTER ALLEGES WOMAN WAS DRIVING IN HER POWERCHAIR AT NIGHT WHEN A SEMI-TRUCK HIT HER RESULTING IN HER DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201441 PRIDE MOBILITY PRODUCTS POWERED WHEELCHAIR ITI PRIDE MOBILITY PRODUCTS Q6 EDGE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death