MAUDE Adverse Event Report: JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD MECHANICAL CHAIR/TRANSPORT CHAIR; 890.3100

Model Number TRAN17FR

Device Problem Torn Material (3024)

Patient Problem Bruise/Contusion (1754)

Event Date 10/09/2013

Event Type  No Answer Provided  

Event Description

It was reported that a elderly man with dementia fell through a transport chair and was found on top of the frame and frightened.They were able to get him up and had him checked by a doctor he suffered bruising.

• Brand Name: MECHANICAL CHAIR/TRANSPORT CHAIR
• Type of Device: 890.3100
• Manufacturer (Section D): JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD; yunyang industrial park; danyang city; jiangsu pro ; CH
• MDR Report Key: 3930190
• MDR Text Key: 16541717
• Report Number: 1531186-2014-02490
• 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: Patient
• Type of Report: Initial
• Report Date: 07/10/2014,06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRAN17FR
• 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: 07/10/2014
• Distributor Facility Aware Date: 06/06/2014
• Device Age: 13 MO
• Date Report to Manufacturer: 07/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 88 MO
• Patient Weight: 66