MAUDE Adverse Event Report: JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD DAILY ACTIVITY ASSIST DEVICES; 890.5050

Model Number 6895

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ulceration (2116)

Event Type  No Answer Provided  

Event Description

Dealer stated that the seat on the (b)(4) shower commode chair is so hard it is causing an ulcer on the end users right side buttock.End user sought medical attention for the level 2 ulcer, has to use the chair 1 hr per day, for showering and for bowel maintenance.Dealer stated that the seat is to hard and rigid for user to sit that long without any movement.No malfunction of the product.Mdr filed based on serious injury.

• Brand Name: DAILY ACTIVITY ASSIST DEVICES
• Type of Device: 890.5050
• Manufacturer (Section D): JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD; yunyang industrial park; danyang city; jiangsu pro ; CH
• MDR Report Key: 4188011
• MDR Text Key: 21876627
• Report Number: 1531186-2014-04977
• Device Sequence Number: 1
• Product Code: IKX
• 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: 10/21/2014,10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6895
• 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: 10/21/2014
• Distributor Facility Aware Date: 10/14/2014
• Device Age: 8 MO
• Date Report to Manufacturer: 10/21/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 MO