MAUDE Adverse Event Report: ELENKER ELENKER STEERABLE KNEE WALKER; WALKER, MECHANICAL

Model Number BO6XB92M6R

Device Problems Loose or Intermittent Connection (1371); Product Quality Problem (1506)

Patient Problem Fall (1848)

Event Date 04/20/2022

Event Type  malfunction  

Event Description

Multiple falls; knee walker is very unstable.The handle bar gets loose daily and it's very dangerous to use.Fda safety report id# (b)(4).

• Brand Name: ELENKER STEERABLE KNEE WALKER
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): ELENKER; 13725 pipeline ave; building 30; chino CA 91710
• MDR Report Key: 14311794
• MDR Text Key: 291231627
• Report Number: MW5109562
• 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
• Type of Report: Initial
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BO6XB92M6R
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 64 KG