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

Model Number LTTB19FR

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

It was reported that the plastic rings on the back and seat upholstery have cracked; 4 on the back and 8 on the seat.

• Brand Name: MECHANICAL CHAIR/TRANSPORT CHAIR
• Type of Device: 890.3100
• Manufacturer (Section D): DANYANG HUAYI MEDICAL SUPPLY&EQUIPMENT CO.,LTD; no.1,zhenxing road; development zone in danyan; jiangsu 2123 00; CH 212300
• MDR Report Key: 4068779
• MDR Text Key: 4854366
• Report Number: 1531186-2014-03944
• 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: Other
• Type of Report: Initial
• Report Date: 09/08/2014,08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LTTB19FR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2014
• Distributor Facility Aware Date: 08/13/2014
• Device Age: 5 MO
• Date Report to Manufacturer: 09/08/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other