MAUDE Adverse Event Report: ZHONGSHAN REXON REHABILITATION EQUIPMENT COMPANY DRIVE MEDICAL; COMMODE CHAIR

Model Number 11117N-1

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fracture, Arm (2351)

Event Type  Injury  

Event Description

(b)(4) received notification of an incident involving a commode chair that (b)(4) imports and distributes.The enduser was attempting to remove the commode bucket and allegedly, the toilet seat became unhinged causing her to fall.She was allegedly taken to the emergency room at (b)(6) hospital and had x-rays taken.She suffered a hairline fracture in her right elbow.The enduser requested a replacement commode chair.

• Brand Name: DRIVE MEDICAL
• Type of Device: COMMODE CHAIR
• Manufacturer (Section D): ZHONGSHAN REXON REHABILITATION EQUIPMENT COMPANY; 56 shangye street; 3th industrial park; chenggui road wuguishan, guangdong 52845 8; CH 528458
• MDR Report Key: 6580216
• MDR Text Key: 75598826
• Report Number: 2438477-2017-00049
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/19/2017,04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 11117N-1
• 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: 05/19/2017
• Distributor Facility Aware Date: 04/21/2017
• Date Report to Manufacturer: 05/19/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR
• Patient Weight: 154