MAUDE Adverse Event Report: JIANGSU YUYUE; WHEELCHAIR

Model Number I1T00690011

Device Problem Device Tipped Over (2589)

Patient Problem Hip Fracture (2349)

Event Date 12/28/2016

Event Type  Injury  

Event Description

(b)(6) daughter reported that (b)(6) was sitting in her wheelchair when she reached over to grab something, and toppled over in her wheelchair.Due to complaint of left hip pain, she was transported to the hospital where x-rays revealed a left hip fracture for which she received surgical intervention.

• Brand Name: UNK
• Type of Device: WHEELCHAIR
• Manufacturer (Section D): JIANGSU YUYUE; CH
• MDR Report Key: 6512653
• MDR Text Key: 73471859
• Report Number: 6512653
• Device Sequence Number: 1
• Product Code: IOR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: I1T00690011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ALTERNATING PRESSURE OVERLAY; BED ALARM PAD; HOSPITAL BED; O2 CONCENTRATOR; OVER BED TABLE; PORTABLE E TANK
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 97 YR
• Patient Weight: 54