MAUDE Adverse Event Report: KI MOBILITY, LLC CATALYST 5VX; MECHANICAL WHEELCHAIR

Model Number CATALYST 5VX

Device Problem Use of Device Problem (1670)

Patient Problems Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Type  Injury  

Event Description

Dealer called in a complaint stating that the end user had 2nd/3rd degree burns on sides and bottom of feet.End user has/had very little feeling in feet so it was not realized until much later.Happened after extended time in the sun this past summer.

• Brand Name: CATALYST 5VX
• Type of Device: MECHANICAL WHEELCHAIR
• Manufacturer (Section D): KI MOBILITY, LLC; 5201 woodward drive; stevens point WI 54481
• Manufacturer (Section G): KI MOBILITY, LLC; 5201 woodward drive; stevens point WI 54481
• Manufacturer Contact: 5201 woodward drive; stevens point, WI 54481 ; 8009811540
• MDR Report Key: 16019479
• MDR Text Key: 305868491
• Report Number: 3005905321-2022-00004
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CATALYST 5VX
• Date Manufacturer Received: 11/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other