MAUDE Adverse Event Report: MAXHEALTH CORP. STEP 'N REST® ROLLING WALKER; ROLLATOR

Model Number FGA22300 0000

Device Problem Fracture (1260)

Patient Problems Head Injury (1879); Suture Abrasion (2497)

Event Date 02/29/2016

Event Type  Injury  

Event Description

Caregiver reported that an (b)(6) woman was walking on a wood floor with a fga22300 0000 rollator, when the wheel fell off, and the whole unit fell apart.The caregiver's son looked at the unit and took it apart, determining there is a plastic piece in the right brake handle.The caregiver and her son believe the brake handle malfunction caused the whole unit to fall apart.The woman was taken by an ambulance to the hospital, as she hit her head when she fell.She had 8 clamps put on her head.

• Brand Name: STEP 'N REST® ROLLING WALKER
• Type of Device: ROLLATOR
• Manufacturer (Section D): MAXHEALTH CORP.; 15f-6, no. 81, sec. 1, hsin; tai wu road, hsi chih; taipei hsien, taiwan 221 ; TW 221
• MDR Report Key: 5568200
• MDR Text Key: 42373302
• Report Number: 2182780-2016-00003
• 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: Other
• Type of Report: Initial
• Report Date: 04/11/2016

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: FGA22300 0000
• Device Catalogue Number: A223-00
• 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: 04/11/2016
• Distributor Facility Aware Date: 03/18/2016
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/11/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR