MAUDE Adverse Event Report:; WHEELCHAIR

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Pain (1994); Hip Fracture (2349)

Event Date 01/09/2018

Event Type  Injury  

Event Description

The patient was in the bathroom on the toilet and the caregiver transferred patient to the wheelchair.The patient slid out of the wheelchair onto the floor and her right leg became wedged between the door and part of the wheelchair.After the fall, the patient was having increased pain and inability to stand, and her right foot appeared to be turned inward.An x-ray was ordered of the right leg that showed an acute fracture of the right femoral neck, displaced about 1cm with mild varus angulation.Hme was notified of the event and the mfr is unk, the wheelchair was the patient's private wheelchair.

• Type of Device: WHEELCHAIR
• MDR Report Key: 7633577
• MDR Text Key: 112321812
• Report Number: 7633577
• Device Sequence Number: 1
• Product Code: IML
• Combination Product (y/n): N
• 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: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/23/2018
• Distributor Facility Aware Date: 01/09/2018
• Device Age: NA
• Event Location: Home
• 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
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 89 YR
• Patient Weight: 54