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

Model Number SC40E GO GO ELITE TRAVELLER 3 WHEEL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

The device was not made available for evaluation at this time.Should further information or the device become available, a follow-up report will be issued.

Event Description

Consumer alleges she fell off of the unit in her house due to a loose tiller.

Manufacturer Narrative

The device was returned and evaluated.The tiller tightened as designed and stayed tight during a test ride.Pride warns to keep the tiller adjustment knob tight in the owner's manual.

Event Description

Consumer alleges she fell off of the unit in her house due to a loose tiller.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: MOTORIZED THREE-WHEELED VEHICLE
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• MDR Report Key: 10385666
• MDR Text Key: 202223401
• Report Number: 2530130-2020-00076
• Device Sequence Number: 1
• Product Code: INI
• UDI-Device Identifier: 00606509300094
• UDI-Public: 00606509300094
• Combination Product (y/n): N
• PMA/PMN Number: K090524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: SC40E GO GO ELITE TRAVELLER 3 WHEEL
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 08/05/2020
• Supplement Dates FDA Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization