MAUDE Adverse Event Report: UNKNOWN UNKNOWN; CHAIR, EXAMINATION AND TREATMENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091); Injury (2348)

Event Date 09/13/2016

Event Type  malfunction  

Event Description

No identifying data available for the chair.(b)(6) around 10am the significant other of the patient was sitting in recliner chair and upon standing from the chair he twisted his ankle by slipping off the black foot rest that was pulled out from underneath the chair.He felt his left ankle twist but did not think it was so bad at the time.This morning i was informed of the incident as the patient states that the pain has increased and has localized swelling.The patient was present for the incident.The rn and cn were not aware of any incident that took place on that day.

• Brand Name: UNKNOWN
• Type of Device: CHAIR, EXAMINATION AND TREATMENT
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 6431660
• MDR Text Key: 70789480
• Report Number: 6431660
• Device Sequence Number: 1
• Product Code: FRK
• 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: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1