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 Date 07/13/2020

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 was riding on a straight sidewalk when the unit allegedly tipped over.

Manufacturer Narrative

The device was returned and evaluated.The alleged event could not be duplicated.

Event Description

Consumer alleges she was riding on a straight sidewalk when the unit allegedly tipped over.

• 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: 10328240
• MDR Text Key: 200480985
• Report Number: 2530130-2020-00073
• 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: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• 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: 08/07/2020
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization