MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; MOTORIZED THREE-WHEELED VEHICLE

Model Number SC713 PURSUIT

Device Problems Unintended Collision (1429); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 01/16/2016

Event Type  Injury  

Manufacturer Narrative

The user was hit by a car when attempting to cross the road.No fault with the device.

Event Description

Client was crossing road when car turned into him.No fault with scooter.Driver did not see him until it was too late.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: MOTORIZED THREE-WHEELED VEHICLE
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 182 susquehanna ave; n/a; exeter PA 18643
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 182 susquehanna ave; n/a; exeter, PA 18643 ; 5706555574
• MDR Report Key: 5382891
• MDR Text Key: 36504544
• Report Number: 2530130-2016-00005
• Device Sequence Number: 1
• Product Code: INI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K092088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SC713 PURSUIT
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization