MAUDE Adverse Event Report: LERADO GLOBAL DAILY ACTIVITY ASSIST DEVICES; 890.5050

Model Number 1302RTS

Device Problem Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2014

Event Type  No Answer Provided  

Event Description

Caregiver states locking mechanism has malfunctioned.Caregiver states seat was unsteady when they went to get up.Customer states that when turning the knob to tighten down, they discovered that the tension bar keeps slipping and it will not move.

• Brand Name: DAILY ACTIVITY ASSIST DEVICES
• Type of Device: 890.5050
• Manufacturer (Section D): LERADO GLOBAL; no. 26-54b,; 7andar h7 edif. centro com; macau ; CH
• MDR Report Key: 4037776
• MDR Text Key: 4801584
• Report Number: 1531186-2014-03475
• 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: Other
• Type of Report: Initial
• Report Date: 08/21/2014,07/24/2014

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: 1302RTS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2014
• Distributor Facility Aware Date: 07/24/2014
• Device Age: 4 MO
• 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): Other