MAUDE Adverse Event Report: TISPORT, LLC TILITE 2GX; MANUAL WHEELCHAIR

Model Number 2GX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Limb Fracture (4518)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

Reports provided to tilite claim as the end-user was attempting to transfer from their motor vehicle to the 2gx manual wheelchair, reports indicate the end-user's foot slipped which caused them to lose balance and fall to the ground.The ensuing fall reportedly resulted with the end-user sustaining a fracture to one of their legs (unspecified as to which leg or bone).No allegations or claims were made indicating the device malfunctioned or deviated in any way to have contributed to this event.All reports received indicate this reported incident was the result of inadvertent use error in the loss of balance during a transfer.The dhr for this device was reviewed and was found to have met specification prior to distribution.

Event Description

Tilite received report claiming as the end-user was attempting to transfer from their motor vehicle into the seating of the manual wheelchair, the end-user reported their foot slipped in process of transferring and this caused them to lose balance and fall to the ground where they sustained an injury requiring medical intervention.

• Brand Name: TILITE 2GX
• Type of Device: MANUAL WHEELCHAIR
• Manufacturer (Section D): TISPORT, LLC; 2701 w. court st.; pasco WA 99301
• Manufacturer Contact: edgar zamarron ; 2701 w. court st.; pasco, WA 99301 ; 5095866117
• MDR Report Key: 12900956
• MDR Text Key: 286333400
• Report Number: 3032618-2021-00009
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2GX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Prefer Not To Disclose