MAUDE Adverse Event Report: UNKNOWN UNKNOWN; CHAIR, ADJUSTABLE, MECHANICAL

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 12/06/2018

Event Type  Injury  

Event Description

The patient was sitting in a recliner in same day surgery.The brakes were applied to the recliner.The patient was obese and was moving around a lot in the chair while trying to get dressed.The recliner moved and the patient fell out of the chair and suffered a fractured ankle.

• Brand Name: UNKNOWN
• Type of Device: CHAIR, ADJUSTABLE, MECHANICAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8605658
• MDR Text Key: 145001305
• Report Number: 8605658
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/05/2019
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 15695 DA