MAUDE Adverse Event Report: POWER SOCCER SHOP, INC./NEMI STRIKE FORCE POWERCHAIR; WHEELCHAIR, POWERED

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2018

Event Type  malfunction  

Event Description

Device wheel chair, powered regulation description powered wheelchair.Product does not comply.Do you have a picture of the product? yes.Non-compliant device.Fda safety report id # (b)(4).

• Brand Name: STRIKE FORCE POWERCHAIR
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): POWER SOCCER SHOP, INC./NEMI
• MDR Report Key: 8654463
• MDR Text Key: 146703065
• Report Number: MW5086982
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other