MAUDE Adverse Event Report: JIANGSU YUYUE MEDICAL EQUIP. MECHANICAL CHAIR/TRANSPORT CHAIR; 890.3100

Model Number TRAN19FR

Device Problems Detachment Of Device Component (1104); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

Dealer alleged that the back upholstery ripped off of the canes.

• Brand Name: MECHANICAL CHAIR/TRANSPORT CHAIR
• Type of Device: 890.3100
• Manufacturer (Section D): JIANGSU YUYUE MEDICAL EQUIP.
• MDR Report Key: 4018196
• MDR Text Key: 20109373
• Report Number: 1531186-2014-03311
• Device Sequence Number: 1
• Product Code: INM
• 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: 08/15/2014,07/17/2014

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: TRAN19FR
• 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: 08/15/2014
• Distributor Facility Aware Date: 07/17/2014
• Date Report to Manufacturer: 08/15/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other