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 07/10/2014

Event Type  No Answer Provided  

Event Description

Dealer stated that the adjustment knob popped out, the hole must be stripped.

• 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: 4005876
• MDR Text Key: 4712506
• Report Number: 1531186-2014-03227
• 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: 08/13/2014,07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2014
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/13/2014
• Distributor Facility Aware Date: 07/10/2014
• Date Report to Manufacturer: 08/13/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other