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

Model Number SC714 PUSUIT XL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

The device has not yet been made available for evaluation.Should further information or the device become available, a follow-up report will then be issued.

Event Description

Provider alleges consumer's scooter wouldn't stop and allegedly went off a porch and tipped over.

Manufacturer Narrative

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

Event Description

Provider alleges consumer's scooter wouldn't stop and allegedly went off a porch and 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: 10676400
• MDR Text Key: 211229252
• Report Number: 2530130-2020-00097
• Device Sequence Number: 1
• Product Code: INI
• UDI-Device Identifier: 00606509300322
• UDI-Public: 00606509300322
• Combination Product (y/n): N
• PMA/PMN Number: K092088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: SC714 PUSUIT XL
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 10/12/2020
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization