MAUDE Adverse Event Report: JUMAO HEALTHCARE EQUIPMENT TRSX5/WD86/ADULT/28FB/BH16/1255/U2222C/U240 9153653564; WHEELCHAIR, MECHANICAL

Model Number TRSX58FBP

Device Problems Device Damaged Prior to Use (2284); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It has been reported by a dealer that a trsx58fbp wheelchair was received with one rear tire with inch slits in the rubber all the way around it.

• Brand Name: TRSX5/WD86/ADULT/28FB/BH16/1255/U2222C/U240 9153653564
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): JUMAO HEALTHCARE EQUIPMENT; jiashan ; CH
• MDR Report Key: 4355671
• MDR Text Key: 5178678
• Report Number: 1531186-2014-06765
• 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: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/22/2014,11/10/2014

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: TRSX58FBP
• 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: 12/22/2014
• Distributor Facility Aware Date: 11/10/2014
• Device Age: 4 MO
• Date Report to Manufacturer: 12/22/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other