MAUDE Adverse Event Report: LERADO - LR - S. CHINA DAILY ACTIVITY ASSIST DEVICES; 890.5050

Model Number 1302RTS

Device Problem Unstable (1667)

Patient Problem Fall (1848)

Event Type  No Answer Provided  

Event Description

Dealer states the end user was using the toilet seat and the front bolt came off causing him to fall and hit his head on the floor.The provider states the end user was discovered unconscious and had to be taken to the er.

• Brand Name: DAILY ACTIVITY ASSIST DEVICES
• Type of Device: 890.5050
• Manufacturer (Section D): LERADO - LR - S. CHINA
• MDR Report Key: 4036988
• MDR Text Key: 4843808
• Report Number: 1531186-2014-03484
• 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: 08/21/2014,07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1302RTS
• 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: 08/21/2014
• Event Location: Home
• Date Report to Manufacturer: 08/21/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization