MAUDE Adverse Event Report: MAXHEALTH CORPORATION COMPASS HEALTH BRANDS; E-SERIES ROLLATOR

Model Number 30164

Device Problem Break (1069)

Patient Problems Fall (1848); Head Injury (1879); Loss of consciousness (2418)

Event Date 03/05/2018

Event Type  Injury  

Event Description

The end-users husband first reported (emailed) that his wife got one of our devices in 2015 after having surgery.On (b)(6) 2018 she sat on it and the right rear leg broke just below the crossbar causing her to fall backward and hit her head and knocked her out.When she fell it caused her to have bleeding on the brain.In a second email from the husband he reported the right rear leg broke just below the crossbar causing her to fall backward and hit her head and knocked her out.He stated she has not been right since and she had a doctor's appointment on (b)(6) 2018.

• Brand Name: COMPASS HEALTH BRANDS
• Type of Device: E-SERIES ROLLATOR
• Manufacturer (Section D): MAXHEALTH CORPORATION; 14f, no. 99, section 1; xintai 5th road; xizhi district new taipei city, taipei ; TW
• MDR Report Key: 7396578
• MDR Text Key: 104364717
• Report Number: 3012316249-2018-00018
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/04/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 30164
• 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: 04/04/2018
• Distributor Facility Aware Date: 03/14/2018
• Date Report to Manufacturer: 04/04/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other