MAUDE Adverse Event Report: UNKNOWN DAILY ACTIVITY ASSIST DEVICES; 890.5050

Model Number 6358

Device Problem Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

The end user's wife called stating the seat is cracked in two places.She feels that it is a flimsy seat and it needs to be sturdier.She took a normal toilet seat and placed it on top of the other one for more support.The bar around the bottom sticks out to far in the front so it's in the way when you stand up so she removed it and put it reversed so the bar is now in the back.She also said that the back upholstery is too close to the seat so you can't lean back in the chair and be on the potty.She thinks it also should have a cup for a male.

• Brand Name: DAILY ACTIVITY ASSIST DEVICES
• Type of Device: 890.5050
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4067139
• MDR Text Key: 15107461
• Report Number: 1531186-2014-03919
• 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: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/05/2014,08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/05/2014
• Distributor Facility Aware Date: 08/13/2014
• Event Location: Home
• Date Report to Manufacturer: 09/05/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other