MAUDE Adverse Event Report: INVACARE TAYLOR STREET ALL-IN-ONE-ALUMINUM COMMODE 4 PER CARTON 9153637754; ADAPTOR, HYGIENE

Model Number 9650-4

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problem Fall (1848)

Event Type  malfunction  

Manufacturer Narrative

Mdr is being submitted as a result of a retrospective complaint review.

Event Description

Dealer stated that the end user sat down on her commode and alleged that the commode fell off resulting in her falling through the commode opening bending the pail holders.Dealer stated the end user fell inside the commode all the way to the ground.

• Brand Name: ALL-IN-ONE-ALUMINUM COMMODE 4 PER CARTON 9153637754
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5623727
• MDR Text Key: 44179557
• Report Number: 1525712-2016-01227
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9650-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Weight: 59