MAUDE Adverse Event Report: UNKNOWN CANE

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 06/23/2014

Event Type  malfunction  

Event Description

Ms.(b)(6) told the dealer that when she started to walk with the cane the frame/upper shaft snapped in half at one of the height adjustment holes.No injury occurred.When the ems sales rep.Visited the store today, he visually inspected the cane and found no ems labeling or serial#.He described the color of the upper shaft to be grayish or a granite shade.Unfortunately, the snapped off portion was thrown away prior to the sales rep.Visit.Dealer has not replaced or refunded the product for the end user as they suspect accidental misuse and want to be sure the cane is covered under warranty.The end user is insistent the cane be replaced at no charge.Forwarded to qam for review.Complaint no.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CANE
• Type of Device: CANE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17524366
• MDR Text Key: 321317728
• Report Number: MW5131313
• Device Sequence Number: 1
• Product Code: IPS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2014

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Patient Age: 69 YR