MAUDE Adverse Event Report: JUMAO HEALTHCARE EQUIPMENT MECHANICAL (MANUAL) WHEELCHAIR; 890.3850

Model Number TREX20RP

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2014

Event Type  No Answer Provided  

Event Description

Provider states that out of box the consumer opened the wheelchair and noticed that a spoke was broken on the right wheel.No additional information provided.

• Brand Name: MECHANICAL (MANUAL) WHEELCHAIR
• Type of Device: 890.3850
• Manufacturer (Section D): JUMAO HEALTHCARE EQUIPMENT; jiashan ; CH
• MDR Report Key: 4058735
• MDR Text Key: 4862274
• Report Number: 1531186-2014-03777
• Device Sequence Number: 1
• Product Code: IOR
• 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: 09/03/2014,08/07/2014

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: TREX20RP
• 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: 08/07/2014
• Device Age: 2 MO
• Date Report to Manufacturer: 09/03/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other