MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; MOTORIZED 3-WHEELED

Model Number TRAVEL PRO ES SC336

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Laceration(s) (1946)

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

Alleges consumer was outside in her carport, a concrete surface.The consumer was turning and the scooter allegedly tipped over and she allegedly fell to the ground.

Manufacturer Narrative

Alleged tip over could not be duplicated.

Event Description

Alleges consumer was outside in her carport, a concrete surface.The consumer was turning and the scooter allegedly tipped over and she allegedly fell to the ground.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: MOTORIZED 3-WHEELED
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; n/a; n/a; n/a, PA 18642 ; 5706024056
• MDR Report Key: 16387007
• MDR Text Key: 309668621
• Report Number: 2530130-2023-00015
• Device Sequence Number: 1
• Product Code: INI
• UDI-Device Identifier: 00606509300568
• UDI-Public: 00606509300568
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: TRAVEL PRO ES SC336
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female