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

Model Number	SC710V VICTORY 10 3 WHEEL VA
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hip Fracture (2349)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exact "date of event" has not been provided.The device has not been made available for evaluation at this time.Should the device or further information become available, a follow-up report will then be issued.
Event or Problem Description
Alleges starting to go in reverse and the unit wouldn't stop going in reverse.Alleges hitting a flower bed and tipped backwards and unit tipped on top of consumer.
Additional Manufacturer Narrative
The device has not been made available for evaluation.Pride has been made party to the suit and will have no further information.
Event or Problem Description
Alleges starting to go in reverse and the unit wouldn't stop going in reverse.Alleges hitting a flower bed and tipped backwards and unit tipped on top of consumer.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: MOTORIZED THREE WHEELED VEHICLE
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• MDR Report Key: 7948115
• Report Number: 2530130-2018-00142
• Device Sequence Number: 14037924
• Product Code: INI
• UDI-Device Identifier: 00606509300346
• UDI-Public: 00606509300346
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K071949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

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: SC710V VICTORY 10 3 WHEEL VA
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization