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

Model Number TRHD22FR

Device Problem Torn Material (3024)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Type  No Answer Provided  

Event Description

Facility (physical therapist) reported that the seat upholstery on a trhd22fr transport chair has a six inch rip on the left, caused the patient to fall.Patient has bruises on back and buttocks, no medical attention.

• 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: 4122718
• MDR Text Key: 4919732
• Report Number: 1531186-2014-04489
• 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: Physical Therapist
• Type of Report: Initial
• Report Date: 09/26/2014,09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2014
• Distributor Facility Aware Date: 09/10/2014
• Device Age: 8 MO
• Date Report to Manufacturer: 09/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 132