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 Pain (1994); Hip Fracture (2349)

Event Date 12/23/2016

Event Type  Injury  

Event Description

(b)(6) found on floor of his room by facility nurse.He reported that he fell forward out of his wheelchair and on his right side while attempting to pick up a banana peel.Pt sent to hospital where x-rays revealed right hip fracture for which he received surgical intervention.(b)(6) notified of incident on (b)(6) 2017.Involved wheelchair is missing from inventory at this time.Medical equipment company unable to provide either manufacturer or serial number.Report will be forwarded to fda.

• Brand Name: UNK
• Type of Device: WHEELCHAIR
• MDR Report Key: 6436023
• MDR Text Key: 71174966
• Report Number: 6436023
• 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: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• 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: 03/16/2017
• Distributor Facility Aware Date: 12/23/2016
• Event Location: Other
• 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): Hospitalization; Required Intervention
• Patient Age: 97 YR
• Patient Weight: 74