MAUDE Adverse Event Report: UMF MEDICAL PODIATRY CHAIR

Model Number 5016-650-100

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2017

Event Type  Injury  

Event Description

Pt was placing on his shoes and the foot rest came off the chair, and he almost fell.The chair was in the lowest position.There is an apparent design flaw in this chair that the company is aware of and has been working with this facility.Replacement parts have been received and being affixed to the foot rests.

• Brand Name: PODIATRY CHAIR
• Type of Device: PODIATRY CHAIR
• Manufacturer (Section D): UMF MEDICAL; johnstown PA
• MDR Report Key: 6812607
• MDR Text Key: 83488909
• Report Number: MW5071738
• Device Sequence Number: 1
• Product Code: INO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5016-650-100
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 95