MAUDE Adverse Event Report: SICHUAN QILI ENTERPRISE INC. PROBASICS; TRANSPORT CHAIR, STEEL

Model Number TCS221612SV

Device Problems Bent (1059); Device Tipped Over (2589)

Patient Problems Fall (1848); Head Injury (1879); Headache (1880); Memory Loss/Impairment (1958); Vertigo (2134)

Event Date 02/23/2018

Event Type  Injury  

Event Description

Information received on 2/28/2018: when the end-user was using the device on the sidewalk in her neighborhood the right front wheel bent and it tipped her sideways to the right.She hit her head and she now has headaches from the fall.The fall aggravated her medical conditions - one of which she said was vertigo and another was the ability to remember words and things.She didn't get medical treatment after the incident.The end-user is also claiming that they received a damaged wheelchair.They mentioned that the wheel seemed bent.Information received on 03/01/2018: the end-user has also stated she hasn't had vertigo for over a year.After the fall she now has vertigo and has started to have headaches.She did not seek any medical treatment and is not taking medication for it.They put the wheels on and it didn't appear to them that the wheel was bent when they put it on.

• Brand Name: PROBASICS
• Type of Device: TRANSPORT CHAIR, STEEL
• Manufacturer (Section D): SICHUAN QILI ENTERPRISE INC.; no. 58 jin peng road c; area luxian industrial park; luzhou city sichuan, ; CH
• MDR Report Key: 7346724
• MDR Text Key: 102712429
• Report Number: 3012316249-2018-00012
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TCS221612SV
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2018
• Distributor Facility Aware Date: 02/23/2018
• Event Location: Other
• Date Report to Manufacturer: 03/16/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 91