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

Model Number TREX20R

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  No Answer Provided  

Event Description

It was reported that the back left arm rest bracket of the (b)(4) wheelchair was bent.

• Brand Name: MECHANICAL (MANUAL) WHEELCHAIR
• Type of Device: 890.3850
• Manufacturer (Section D): JUMAO MEDICAL EQUIPMENT; jiashan ; CH
• MDR Report Key: 3849532
• MDR Text Key: 17929099
• Report Number: 1531186-2014-02093
• 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: 06/04/2014,04/22/2014

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: TREX20R
• 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: 06/04/2014
• Distributor Facility Aware Date: 04/22/2014
• Device Age: 16 MO
• Date Report to Manufacturer: 06/04/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other