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

Model Number	CATALYST 5
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
User is unhappy with the chair in general and recently fell out of the chair when transferring causing her to break her femur.Accident happened in january and spent some time in hospital.Once dealer received the chair for evaluation, (b)(6) asked them not to do anything with the chair until he could look at it.No parts/action to be taken at this time.
Additional Manufacturer Narrative
This report is being filed out of an overabundance of caution due to the nature of the injury.The device has not been returned and no parts have been requested as a result of this adverse event.A follow-up will be conducted if more information becomes available.The complaint submitted does not make any claims that the device malfunctioned or deviated in any way that would have contributed to this event.

• Brand Name: CATALYST 5
• Common Device Name: 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: 16034178
• Report Number: 3005905321-2022-00007
• Device Sequence Number: 12169749
• Product Code: IOR
• UDI-Device Identifier: 00850013379026
• UDI-Public: 00850013379026
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K062660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: CATALYST 5
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 12/22/2022
• Date Device Manufactured: 04/19/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown