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

Model Number	GO GO ES 2 3 WHEEL (S81)
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
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 he was turning into the bedroom, the back wheel caught the door, and the unit allegedly tipped over with arnold in it.He believed he wasn't making a turn at that moment and that it was more of a straight away and didn't clear successfully.
Additional Manufacturer Narrative
Follow-up to add: date of loss.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 he was turning into the bedroom, the back wheel caught the door, and the unit allegedly tipped over with arnold in it.He believed he wasn't making a turn at that moment and that it was more of a straight away and didn't clear successfully.
Additional Manufacturer Narrative
Per tech: replaced tiller and batteries.Unit is working properly.Parts never received back for evaluation.
Event or Problem Description
Consumer's wife alleges he was turning into the bedroom, the back wheel caught the door, and the unit allegedly tipped over with arnold in it.He believed he wasn't making a turn at that moment and that it was more of a straight away and didn't clear successfully.

• 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: 19700301
• Report Number: 2530130-2024-00474
• Device Sequence Number: 7785382
• Product Code: INI
• UDI-Device Identifier: 00606509300148
• UDI-Public: 00606509300148
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K090524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2025

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 ES 2 3 WHEEL (S81)
• 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: 06/28/2024
• Supplement Date Received by Manufacturer: 06/28/2024; 06/28/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/20/2024; 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2023
• 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: Hospitalization
• Patient Sex: Male