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

Model Number	S613 LUNA VICTORY
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	05/17/2024
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
Provider alleges consumer alleges scooter kept driving without deceleration after the end user allegedly released the throttle handle.As a result thereof, scooter allegedly collided with a vehicle on a roundabout and the end user hurt his arm.
Event or Problem Description
Provider alleges consumer alleges scooter kept driving without deceleration after the end user allegedly released the throttle handle.As a result thereof, scooter allegedly collided with a vehicle on a roundabout and the end user hurt his arm.
Additional Manufacturer Narrative
Per pride bv: welzorg informed us that their mechanic inspected the device in question but found no faults/issues.Still, as a precaution, soft stop was disabled.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: 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 18642 ; 8008008586
• MDR Report Key: 19788796
• Report Number: 2530130-2024-00487
• Device Sequence Number: 15390926
• Product Code: INI
• UDI-Device Identifier: 00606509300254
• UDI-Public: 00606509300254
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K092088
• 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): 08/14/2024

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: S613 LUNA VICTORY
• 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: 07/04/2024
• Supplement Date Received by Manufacturer: 07/04/2024
• Initial Report FDA Received Date: 07/21/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2021
• 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: Unknown