MAUDE Adverse Event Report: SCOOTER

Model Number 86498

Device Problems Failure to Charge (1085); Device Emits Odor (1425); Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 02/22/2018

Event Type  No Answer Provided  

Event Description

Reporter states that she was delivered a scooter at her home yesterday (b)(6) 2018 and it is not working.According to reporter, the scooter would not charge despite the fact that it was plugged all night.She also mentioned that the scooter was emitting a very strong smell that was disturbing to her.Reporter is requesting for a new scooter as soon as possible.Reporter was able to provide the name of the distributor (b)(4) but did not have the name of the manufacturer.

• Brand Name: SCOOTER
• Type of Device: SCOOTER
• MDR Report Key: 7295990
• MDR Text Key: 101145693
• Report Number: MW5075523
• Device Sequence Number: 1
• Product Code: KNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/23/2018

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?: No
• Device Operator: No Information
• Device Model Number: 86498
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1