MAUDE Adverse Event Report: MAXHEALTH CORP. DUAL PADDLE ADULT FOLDING WALKER

Model Number FGA84700 0000

Device Problems Mechanical Problem (1384); Physical Property Issue (3008)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/08/2016

Event Type  Injury  

Event Description

The end-user is a (b)(6) woman who uses a walker.On (b)(6) 2016, the end-user suffered a fall on the street while the right tube folded on the walker.The end-user claims that the (right side) spring that controls the brass push pin on the leg of the walker had not provided eough pressure to allow the leg to lock into place, thus resulting in the leg folding and destabilizing the walker, eventually resulting in her fall to the ground.The right spring is claimed to have a different shape than the left spring, being folded in at its body and tip - hence why there was no clamping, and the brass button did not lock thru the slot; this part was loose, causing the extensible leg on the walker frame to fold.The end-user reported that she suffered from pain and mechanical dorsalgia since the fall.The end-user claims that the injury she sustained had created her an exacerbation of her current pathology.Item# originally listed as fga84300 0000 3" urethane walker wheels in complaint (leg extenstions with wheels) - however actual walker item# involved fga84700 0000.

• Brand Name: DUAL PADDLE ADULT FOLDING WALKER
• Type of Device: WALKER
• 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: 6064864
• MDR Text Key: 58699834
• Report Number: 3005182235-2016-00037
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/28/2016,10/25/2016

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: FGA84700 0000
• Device Catalogue Number: A847-00
• Device Lot Number: N/A
• 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: 10/28/2016
• Distributor Facility Aware Date: 09/30/2016
• Event Location: Other
• Date Report to Manufacturer: 10/28/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR