BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRIDE MOBILITY PRODUCTS

    MDR report key: 6424320 · Received March 22, 2017

    Report

    Report Number
    2530130-2017-00037
    Event Type
    Death
    Date Received
    March 22, 2017
    Date of Event
    November 4, 2015
    Report Date
    October 19, 2017
    Manufacturer
    PRIDE MOBILITY PRODUCTS
    Product Code
    INI
    PMA / PMN Number
    K063389
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE MODEL NUMBER, SERIAL NUMBER, AND THE DATE OF MANUFACTURE HAVE NOT BEEN PROVIDED. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR EVALUATION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE MODEL NUMBER, SERIAL NUMBER, AND THE DATE OF MANUFACTURE HAVE BEEN UPDATED. 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 SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT THE CAUSE OF THE ALLEGED INCIDENT.

    Description of Event or Problem · 1

    RECEIVED WRIT OF ADDITIONAL DEFENDANTS, INVESTIGATED AND FOUND THAT PLAINTIFF CLAIMS SHE ENTERED COMBINED PASSENGER AND FREIGHT ELEVATOR STRAIGHT ON GROUND FLOOR. SHE INTENDED TO GO TO APARTMENT ON 17TH FLOOR. ALLEGEDLY, THE ELEVATOR STOPPED SHORT OF 17TH AND WHEN SHE BACKED OUT THE SCOOTER TUMBLED AND SHE WAS INJURED.

    Description of Event or Problem · 1

    RECEIVED WRIT OF ADDITIONAL DEFENDANTS, INVESTIGATED AND FOUND THAT PLAINTIFF CLAIMS SHE ENTERED COMBINED PASSENGER AND FREIGHT ELEVATOR STRAIGHT ON GROUND FLOOR. SHE INTENDED TO GO TO APARTMENT ON 17TH FLOOR. ALLEGEDLY, THE ELEVATOR STOPPED SHORT OF 17TH AND WHEN SHE BACKED OUT THE SCOOTER TUMBLED AND SHE WAS INJURED.

    Description of Event or Problem · 1

    RECEIVED WRIT OF ADDITIONAL DEFENDANTS, INVESTIGATED AND FOUND THAT PLAINTIFF CLAIMS SHE ENTERED COMBINED PASSENGER AND FREIGHT ELEVATOR STRAIGHT ON GROUND FLOOR. SHE INTENDED TO GO TO APARTMENT ON 17TH FLOOR. ALLEGEDLY, THE ELEVATOR STOPPED SHORT OF 17TH AND WHEN SHE BACKED OUT THE SCOOTER TUMBLED AND SHE WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207491 PRIDE MOBILITY PRODUCTS MOTORIZED THREE-WHEELED VEHICLE INI PRIDE MOBILITY PRODUCTS SC44E GO GO ELITE TRAVELLER 4 WHEEL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death