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

Model Number	VICTORY 10 4 WHEEL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	07/18/2024
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 he was tossed from the unit due too the swivel lever on the seat allegedly being loose.
Event or Problem Description
Provider alleges consumer alleges he was tossed from the unit due too the swivel lever on the seat allegedly being loose.
Additional Manufacturer Narrative
The handle on the seat plate was bent and caused the locating peg not to align properly with the clover leaf on the seat post.This is supported by the coating missing from the handle indicating stress.The misalignment and force also caused the clover leaf notch to elongate.This damage was clearly post final release/customer misuse.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: VEHICLE, MOTORIZED 3-WHEEL
• 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
• MDR Report Key: 19891366
• Report Number: 2530130-2024-00516
• Device Sequence Number: 7114695
• Product Code: INI
• UDI-Device Identifier: 00606509300346
• UDI-Public: 00606509300346
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K092961
• 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): 09/26/2024

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 10 4 WHEEL
• 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: 07/24/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2024
• 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