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

Model Number	SC53 GO GO ELITE TRAVELLER PLUS 3 WHEEL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Hip Fracture (2349)
Date of Event	12/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been made available for evaluation.Should the device become available or further information be received, a follow-up report will then be issued.
Event or Problem Description
Alleges coming out of house and scooter caught on the small step up.Alleges the speed was turned low but somehow it moved higher.Alleges when the wheel caught, it shot out and went off the porch.
Additional Manufacturer Narrative
The device was evaluated by a field service technician.Nothing wrong with scooter.It functions exactly as it should and is not damaged either.Tech was not able to get pictures of the ramp in question, as it was not the ramp at the customer's home.No extra steps needed.Unit working properly.
Event or Problem Description
Alleges coming out of house and scooter caught on the small step up.Alleges the speed was turned low but somehow it moved higher.Alleges when the wheel caught, it shot out and went off the porch.
Additional Manufacturer Narrative
The "patient identifier" and the "initial reporter" have been updated with provided information.The device has not yet been made available for evaluation.Should the device become available or further information be received, a follow-up report will then be issued.
Event or Problem Description
Alleges coming out of house and scooter caught on the small step up.Alleges the speed was turned low but somehow it moved higher.Alleges when the wheel caught, it shot out and went off the porch.

• 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: 11147587
• Report Number: 2530130-2021-00003
• Device Sequence Number: 10974547
• Product Code: INI
• UDI-Device Identifier: 00606509300124
• UDI-Public: 00606509300124
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K062160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2021

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: SC53 GO GO ELITE TRAVELLER PLUS 3 WHEEL
• 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: 01/04/2021
• Supplement Date Received by Manufacturer: 01/04/2021; 01/04/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 01/18/2021; 02/01/2021
• 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