MAUDE Adverse Event Report: EASY RISE WALKER; WALKER, MECHANICAL

Model Number 354773

Device Problem Material Twisted/Bent (2981)

Patient Problems Fall (1848); Laceration(s) (1946); Concussion (2192)

Event Date 11/12/2021

Event Type  Death  

Event Description

Concussion, head laceration.The product was purchased for the sit stand option for my brother (b)(6) years old by my mother from (b)(6) company in (b)(6).Walker number (b)(4).The walker was removed from box and opened per instructions however when my brother tried to turn walker to face direction he wished to go the top twisted on him causing him to lose his balance and fall to ground.Company offered a (b)(6) gift voucher and asked us to return walker.I did not for fear it would not be reported as a hazardous device.Which i feel hastened my brothers death from the head injury he sustained.Please review product for safety and recall.Thank you.Fda safety report id # (b)(4).

• Brand Name: EASY RISE WALKER
• Type of Device: WALKER, MECHANICAL
• MDR Report Key: 13176762
• MDR Text Key: 283427077
• Report Number: MW5106483
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/04/2022

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: 354773
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Death
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic