MAUDE Adverse Event Report: PINGHU WEIFENG MATERIAL TECHNOLOGY DAILY ACTIVITY ASSIST DEVICES; 890.5050

Model Number SELFCARE

Device Problem Collapse (1099)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

Per dealer, the legs collapsed patient not injured.

• Brand Name: DAILY ACTIVITY ASSIST DEVICES
• Type of Device: 890.5050
• Manufacturer (Section D): PINGHU WEIFENG MATERIAL TECHNOLOGY; pinghu ; CH
• MDR Report Key: 4055311
• MDR Text Key: 16563810
• Report Number: 1531186-2014-03754
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/02/2014,08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SELFCARE
• 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: 09/02/2014
• Distributor Facility Aware Date: 08/07/2014
• Date Report to Manufacturer: 09/02/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other