MAUDE Adverse Event Report: BIGALEX FOLDING WALKING CANE WITH LED LIGHT,PIVOTING QUAD BASE,ADJUSTABLE WALKIN

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 01/08/2021

Event Type  malfunction  

Event Description

I was using this cane when the flexible foot fell off and can't be reattached.Bigalex folding walking cane with led light,pivoting quad base, adjustable walking stick with carrying bag for man/woman.Fda safety report id # (b)(4).

• Brand Name: BIGALEX FOLDING WALKING CANE WITH LED LIGHT,PIVOTING QUAD BASE,ADJUSTABLE WALKIN
• Type of Device: CANE
• MDR Report Key: 11177555
• MDR Text Key: 227598365
• Report Number: MW5098847
• Device Sequence Number: 1
• Product Code: IPS
• 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: 01/13/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 129