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

Model Number	MAXIMA 3 WHEEL SC901
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	10/23/2023
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
Provider alleges consumer was getting off of the scooter seat to get into their vehicle.While getting off of the seat, the swivel lever on the seat mount allegedly broke loose allegedly causing the seat to spin and throwing the customer to the asphalt.
Additional Manufacturer Narrative
Seat only- the seat lever was not returned for examination.The post for the lever was fractured.(the remnant post was not returned for examination) it is unknown what caused this fracture.
Event or Problem Description
Provider alleges consumer was getting off of the scooter seat to get into their vehicle.While getting off of the seat, the swivel lever on the seat mount allegedly broke loose allegedly causing the seat to spin and throwing the customer to the asphalt.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: POWERED VEHICLE, MOTORIZED 3-WHEELED
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea 18642
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 401 york avenue; duryea 18342 ; 8008008586
• MDR Report Key: 18901800
• Report Number: 2530130-2024-00345
• Device Sequence Number: 9136080
• Product Code: INI
• UDI-Device Identifier: 00606509300544
• UDI-Public: 00606509300544
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K091113
• 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): 06/06/2024

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: MAXIMA 3 WHEEL SC901
• 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: 02/28/2024
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2023
• 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: Other
• Patient Sex: Male