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

Model Number	SC609 VICTORY 9 3 WHEEL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Neck Pain (2433); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been made available for evaluation as of yet.Should the device or further information become available, a follow-up report will then be issued.
Event or Problem Description
Consumer alleges scooter took off and allegedly ran into her daughter and allegedly hurt her ankle.The scooter allegedly took off, consumer's son pulled the keys and it allegedly still didn't stop.Scooter allegedly went up a curb, into a flower bed and into a wall with a statue.
Event or Problem Description
Consumer alleges scooter took off and allegedly ran into her daughter and allegedly hurt her ankle.The scooter allegedly took off, consumer's son pulled the keys and it allegedly still didn't stop.Scooter allegedly went up a curb, into a flower bed and into a wall with a statue.
Additional Manufacturer Narrative
The alleged condition(s) could not be duplicated.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: MOTORIZED 3-WHEELED VEHICLE
• 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 ave; duryea, PA 18642 ; 8008008586
• MDR Report Key: 12494943
• Report Number: 2530130-2021-00098
• Device Sequence Number: 11662189
• Product Code: INI
• UDI-Device Identifier: 00606509300377
• UDI-Public: 00606509300377
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K072165
• 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): 04/28/2022

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: SC609 VICTORY 9 3 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: 09/13/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2021
• 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: Hospitalization
• Patient Sex: Female