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

Model Number 9830-4

Device Problem Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 09/22/2014

Event Type  No Answer Provided  

Event Description

Per provider: missing back frames out of box.

• 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: 4192570
• MDR Text Key: 4963944
• Report Number: 1531186-2014-05004
• 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: 10/22/2014,09/22/2014

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: 9830-4
• 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: 10/22/2014
• Distributor Facility Aware Date: 09/22/2014
• Date Report to Manufacturer: 10/22/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other