MAUDE Adverse Event Report: RALON MEDICAL EQUIPMENT CO. LTD. DAILY ACTIVITY ASSIST DEVICES; 890.5050

Model Number 6599

Device Problems Break (1069); Out-Of-Box Failure (2311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

Dealer stated that the arm on a 6599 bariatric commode was broken, out of the box.

• Brand Name: DAILY ACTIVITY ASSIST DEVICES
• Type of Device: 890.5050
• Manufacturer (Section D): RALON MEDICAL EQUIPMENT CO. LTD.; xilian development zone; jinsha, danzao town 5282 22; CH 528222
• MDR Report Key: 3844578
• MDR Text Key: 4657130
• Report Number: 1531186-2014-02055
• 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: 06/02/2014,02/20/2014

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: 6599
• 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: 06/02/2014
• Distributor Facility Aware Date: 02/20/2014
• Device Age: 1 YR
• Date Report to Manufacturer: 06/02/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/03/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other