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

Model Number	VICTORY LX SPORT (S710LXW)
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	10/20/2024
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
Rep alleges the provider alleges that the unit moves on its own and that there is a burning smell.Also, an employee was on the unit and it allegedly drove into a wall without the wigwag being touched.
Additional Manufacturer Narrative
The evaluator was able to recreate the unintended movement but the speed (1/2 mph) and distance (1 foot) was not consistent with type of force needed to cause a major impact with a wall.Mechanical engineering was able to determine that a motor failure with overheating occurred causing severe varnish contamination of the brake area (phenolic disc) further, the unintended motion (rolling) after the throttle was release resulting from this failure was likely because the amperage ramped up to overcome the impaired motor and seized brake and would bleed off the energy.The owner's manual contains language to keep one's feet on the floorboard.
Event or Problem Description
Rep alleges the provider alleges that the unit moves on its own and that there is a burning smell.Also, an employee was on the unit and it allegedly drove into a wall without the wigwag being touched.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: VEHICLE, MOTORIZED THREE-WHEELED
• 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: 20693415
• Report Number: 2530130-2024-00646
• Device Sequence Number: 18318035
• Product Code: INI
• UDI-Device Identifier: 00606509300438
• UDI-Public: 00606509300438
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K071949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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: VICTORY LX SPORT (S710LXW)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2023
• 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: Female