MAUDE Adverse Event Report: KENSTONE METAL DAILY ACTIVITY ASSIST DEVICES; 890.5050

Model Number 6895

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

Per dealer, brakes not holding.

• Brand Name: DAILY ACTIVITY ASSIST DEVICES
• Type of Device: 890.5050
• Manufacturer (Section D): KENSTONE METAL; kunshan ; CH
• MDR Report Key: 3919283
• MDR Text Key: 17578977
• Report Number: 1531186-2014-02429
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/08/2014,06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6895
• 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: 07/08/2014
• Distributor Facility Aware Date: 06/04/2014
• Device Age: 2 YR
• Date Report to Manufacturer: 07/08/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other