MAUDE Adverse Event Report: UNKNOWN SCOOTER MIDSIZE 3 WHEEL SILVER 9153652403; VEHICLE, MOTORIZED 3-WHEELED

Model Number UNKNOWN

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported by end user's son that the throttle assembly for the unknown model scooter is broken.Only the spring is missing.

• Brand Name: SCOOTER MIDSIZE 3 WHEEL SILVER 9153652403
• Type of Device: VEHICLE, MOTORIZED 3-WHEELED
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: karen loughren ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4385834
• MDR Text Key: 15109200
• Report Number: 1525712-2014-08434
• Device Sequence Number: 1
• Product Code: INI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2014
• Initial Date FDA Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other