MAUDE Adverse Event Report: JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD HVY DUTY TRANSPORT 22 IN-W/FTRST 9153643753; WHEELCHAIR, MECHANICAL

Model Number TRHD22FR

Device Problems Hole In Material (1293); Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2014

Event Type  malfunction  

Event Description

Per dealer the end user stated, the seat has ripped along the seam on the right side near the front.

• Brand Name: HVY DUTY TRANSPORT 22 IN-W/FTRST 9153643753
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD; yunyang industrial park; danyang city; jiangsu pro ; CH
• MDR Report Key: 4401620
• MDR Text Key: 5365375
• Report Number: 1531186-2015-00155
• 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: 01/08/2015,12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRHD22FR
• 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: 01/08/2015
• Distributor Facility Aware Date: 12/18/2014
• Device Age: 5 MO
• Date Report to Manufacturer: 01/08/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other