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

Model Number	SC610 VICTORY 10 3 WHEEL
Medical Device Problem Codes	Device Tipped Over (2589); Unintended Movement (3026)
Health Effect - Clinical Codes	Abrasion (1689); Bruise/Contusion (1754)
Date of Event	09/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been made available for evaluation.Should the device or further information become available, a follow-up report will then be issued.
Event or Problem Description
Alleges going back into his building when the unit stopped.Alleges unit engaged itself and started going backwards.Alleges turning unit off and took out the key but it continued to go backwards.Alleges it went approximately 100 yards and then it hit a hole and tipped over and landed on him.
Additional Manufacturer Narrative
An fst evaluated the device and replaced with a new device in the field.The new unit is working properly.The old unit was returned as per the fst but it cannot be located for evaluation.
Event or Problem Description
Alleges going back into his building when the unit stopped.Alleges unit engaged itself and started going backwards.Alleges turning unit off and took out the key but it continued to go backwards.Alleges it went approximately 100 yards and then it hit a hole and tipped over and landed on him.

• 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: 7911441
• Report Number: 2530130-2018-00131
• Device Sequence Number: 19348796
• Product Code: INI
• UDI-Device Identifier: 00606509300339
• UDI-Public: 00606509300339
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K072165
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2019

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: SC610 VICTORY 10 3 WHEEL
• 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: 09/20/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 09/10/2019
• 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