MAUDE Adverse Event Report: POPULAR PLASTICS DAILY ACTIVITY ASSIST DEVICES; 890.5050

Model Number 9780

Device Problem Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

Provider states that the chair's legs spread out and don't stay locked at set height when the water runs on it.Although weight not provided, provider states the patient is well within the weight limit.

• Brand Name: DAILY ACTIVITY ASSIST DEVICES
• Type of Device: 890.5050
• Manufacturer (Section D): POPULAR PLASTICS; guangzhou & donggua ; CH
• MDR Report Key: 4058377
• MDR Text Key: 4735275
• Report Number: 1531186-2014-03773
• 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: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/03/2014,08/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9780
• 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: 09/03/2014
• Distributor Facility Aware Date: 08/11/2014
• Device Age: 5 MO
• Date Report to Manufacturer: 09/03/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other