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

Model Number 9630-4

Device Problems Unstable (1667); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

End user states that his wife was using the unit and the rear legs have buckled.Received second hand assembled.

• Brand Name: DAILY ACTIVITY ASSIST DEVICES
• Type of Device: 890.5050
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4041085
• MDR Text Key: 16994919
• Report Number: 1531186-2014-03576
• 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: 08/26/2014,08/01/2014

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: Other
• Device Model Number: 9630-4
• 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: 08/26/2014
• Distributor Facility Aware Date: 08/01/2014
• Date Report to Manufacturer: 08/26/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other