MAUDE Adverse Event Report: WIELAND DESIGNS INC. RECLINING CHAIRS; CHAIR, EXAMINATION AND TREATMENT

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Reclining chairs easily tip forward when leg rest is out.Contributed to patient falls.Fda safety report id # (b)(6).

• Brand Name: RECLINING CHAIRS
• Type of Device: CHAIR, EXAMINATION AND TREATMENT
• Manufacturer (Section D): WIELAND DESIGNS INC.
• MDR Report Key: 12438683
• MDR Text Key: 270669666
• Report Number: MW5103754
• Device Sequence Number: 1
• Product Code: FRK
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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