MAUDE Adverse Event Report: MAXHEALTH CORP DRIVE MEDICAL; MECHANICAL CHAIR

Model Number RTLFW19RW-RD

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/30/2016

Event Type  Injury  

Event Description

(b)(4) received notice regarding the incident from the end user, involving a transport chair, a product imported and distributed by (b)(4).While the end user was being pushed down the sidewalk, they hit an expansion joint on the sidewalk causing him to allegedly fall and land on his left shoulder.The left shoulder was fractured.This report is based on the information that was provided by the end user.

• Brand Name: DRIVE MEDICAL
• Type of Device: MECHANICAL CHAIR
• Manufacturer (Section D): MAXHEALTH CORP; 15f-6 no 81, hsin tai wu rd; sec 1; taipei hsien taipei, hsi chih ; TW
• MDR Report Key: 5918169
• MDR Text Key: 53613178
• Report Number: 2438477-2016-00039
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/31/2016,08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Patient Family Member or Friend
• Device Model Number: RTLFW19RW-RD
• 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: 08/31/2016
• Distributor Facility Aware Date: 08/01/2016
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 08/31/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention