MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; VEHICLE, MOTORIZED 3-WHEEL

Model Number	GO GO ELITE TRAVELER 4 WHEEL SC44E
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been made available for evaluation.Should further information or the device become available, a follow-up report will then be issued.
Event or Problem Description
Consumer's wife alleges her husband was reversing it off the lift on the back of the vehicle when the scooter allegedly flipped up in the air and her husband fell out of the unit.Consumer's wife alleges the lift was fully on the ground when the scooter jumped and flipped.
Event or Problem Description
Consumer's wife alleges her husband was reversing it off the lift on the back of the vehicle when the scooter allegedly flipped up in the air and her husband fell out of the unit.Consumer's wife alleges the lift was fully on the ground when the scooter jumped and flipped.
Additional Manufacturer Narrative
Job completed on (b)(6) 2024.The unit is working properly.The lift does not go all the way to the ground.Tech also advised them to never be on the unit when loading or unloading the scooter.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: VEHICLE, MOTORIZED 3-WHEEL
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 401 york avenue; duryea, PA 18642 ; 8008008586
• MDR Report Key: 20852829
• Report Number: 2530130-2024-00665
• Device Sequence Number: 8256003
• Product Code: INI
• UDI-Device Identifier: 00606509300100
• UDI-Public: 00606509300100
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K063389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: GO GO ELITE TRAVELER 4 WHEEL SC44E
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male